Import Alert 89-08
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
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Import Alert Name:
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Reason for Alert:
Guidance:
Product Description:
Medical Devices
Charge:
Countries
Desc: Gynecological devices (Small #2; Medium #3; Large #4) Notes: Autoexpandable and Discardable Speculum for Gynecological Use Models
Desc: Interfall Hydrogel Products Notes: Class III. Interfall Hydrogel is a dermal filler marketed for; shaping the face; genitals; mammary glands and buttocks; elimination of deep deforming scars; and endoprosthetics of vocal cords in cases of paralytic stenosis of the larynx; as well as other purposes. Firm name could also be listed in records as Minasian Medical Centre and/or www.consultdrminas.com.
Desc: Interfall Hydrogel Products Notes: Class III. Interfall Hydrogel is a dermal filler marketed for; shaping the face; genitals; mammary glands and buttocks; elimination of deep deforming scars; and endoprosthetics of vocal cords in cases of paralytic stenosis of the larynx; as well as other purposes. Firm name could also be listed in records as Minasian Medical Centre and/or www.consultdrminas.com.
Desc: Better Breathing Sport
Desc: Better Breathing Kids
Desc: Better Breathing Sport
Desc: Better Breathing Kids
Notes: All devices. DE. Seasonal Affective Disorder Devices. (SAD Devices)
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Notes: Therapeutic Ionisers; Class III; 12/26/
Desc: EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT)
Desc: MB COVID-19 Antibody Rapid Detection Test
Desc: MB COVID-19 Antibody Rapid Detection Test
Desc: MB COVID-19 Antibody Rapid Detection Test
Desc: MB COVID-19 Antibody Rapid Detection Test
Notes: MEDEC BioResonance System
Desc: COVID-19 Rapid Test
Desc: COVID-19 Rapid Test
Desc: COVID-19 Rapid Test
Desc: LIAISON IQ reader
Notes: HIV Oral Test (aka 1; 2 and Subtype O Saliva Test). 10/26/. Note
HIV Diagnostic Kits are Class III devices within the meaning of
Section 513(f)(1) of the Act and are regulated by CBER under the
current intercenter agreement between CDRH and CBER. The unapproved
diagnostic test kits claim to detect HIV antibodies in blood or
saliva and provide results in the home in 15 minutes or less. The
test kits are imported into the US through the mail and may be
entered as Asamples@ or for Apersonal usa@. The contents may be
labeled Afor investigational use@ for Aresearch use@ or Afor export
only @. The test kits could present a serious hazard to the public
health; including possible HIV transmission to partners and delayed
access to medical care due to mis-diagnosed false negative tests. If
entries are encounted; contact CBER Import/Export team at 301-827-
.
Notes: HIV Oral Test (aka 1; 2 and Subtype O Saliva Test). 10/26/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: SeptiCyte RAPID
Desc: CoV-2 Rapid Antigen Test
Desc: Covelex
Desc: Multi-g COVID-19 IgG/IgM Rapid Test
Desc: QuickZen COVID-19 IgM / IgG
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Notes: HIV 2 Blood Test Kit. (aka HIV Testing Kit) HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-. 11/9/
Notes: HIV 2 Blood Test Kit. (aka HIV Testing Kit) HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-. 11/9/
Notes: HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Notes: HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: Chisoft Neck Stretcher
Desc: T.E.N.S. Pro 900 Energy Point Stimulator Notes: Class III
Notes: 12/15/ Angelcare sound & Breathing Frequency Monitor.
Notes: HIV 1 & 2 ELISA. 7/10/. HIV Diagnostic Kits are Class III
devices within the meaning of Section 513(f)(1) of the Act and are
regulated by CBER under the current intercenter agreement between
CDRH and CBER. The unapproved diagnostic test kits claim to detect
HIV antibodies in blood or saliva and provide results in the home in
15 minutes or less. The test kits are imported into the US through
the mail and may be entered as Asamples@ or for Apersonal usa@. The
contents may be labeled Afor investigational use@ for Aresearch use@
or Afor export only @. The test kits could present a serious hazard
to the public health; including possible HIV transmission to
partners and delayed access to medical care due to mis-diagnosed
false negative tests. If entries are encounted; contact CBER
Import/Export team at 301-827-.
Notes: HIV 1 & 2 ELISA. 7/10/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Notes: All devices. GPI = DE. Revitalite Beautifying Soft Light Laser
Desc: GenomeCov19 Detection Kit
Notes: Eye Mask or Eye Masque.
Desc: Ark Bio Microwave Plasma Defroster
Desc: COVID-19 IgM/IgG Antibody Test
Desc: COVID-19 IgM/IgG Antibody Test
Desc: OTO-Artron COVID-19 IgM/IgG Antibody Rapid Detection
Desc: Artron COVID-19 Antigen Test
Desc: COVID-19 IgM/IgG Antibody Test
Desc: COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)
Desc: COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)
Desc: COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)
Desc: Tell Me Fast
Desc: Tell Me Fast Novel Coronavirus (COVID19) IgG/IgM Antibody Test Strip
Desc: INSTI COVID-19 Antibody Test
Desc: INSTI COVID-19 Antibody Test
Desc: Faceshield with one-way valve and filter
Desc: Faceshield with one-way valve and filter
Desc: Rapid Response COVID-19 Antigen Rapid Test Device
Desc: Rapid Response COVID-19 Antigen Rapid Test Device
Notes: HIV 1/2 Saliva Test Kit (aka Easy Home Test or easyhivtest). 9/14/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: Porcine Pericardial Patch Notes: Class II
Desc: Injectable Bio-Pulmonic Pulmonic Valve Notes: Class III
Desc: BioMitral Bio-Aortic Replacement Aortic and Mitral Valve Notes: Class III
Desc: MitroFix Mitral Valve Restoration
Desc: Bone Growth Stimulator Notes: Class III; 10/28/
Desc: Bone Growth Stimulator Notes: Class III; 10/28/
Desc: Needlesafe; all models; including NX; NX; NX; NX SDS Notes: 8/19/
Desc: Sharpes Container sold with Model NX SDS and alone Notes: 8/19/
Desc: Persona Contraceptive Monitor Notes: Class III device 5/8/
Desc: Pelican COVID-19 Ultra-Rapid Mobile Test for At-Home Testing
Desc: CoviLampTM SARS-CoV-2 High-throughput Fluorometric Test Kit
Desc: CoviLamp High- throughput Fluorometric Test Kit
Desc: CoviLamp Fluorometric Test Kit
Desc: CoviLAMP Screening Kit for SARS-CoV-2
Desc: Victoria Machine/cranial electro stimulator (modes; Gem zapper; cranial electro stimulator; colloidial silver; blood electrifier) Device Notes: Class II
Desc: Magnetic Pulser (1Amp Fuse; 110VAC) Device Notes: Class II
Desc: Ultimate Cancer Care (modes; zapper; sarcoma; carcinoma; colloidal silver) device and accessories; Notes: Class II
Desc: Electric massager (part 1 & 2; HIC - & HIC -); TDP CP-27IR-Heater Lamp Notes: Class II
Desc: Tri-Medica (modes; gem zapper; colloidial silver; blood electrifier) Notes: Class II
Desc: Electric massager (part 1 & 2; HIC - & HIC -); TDP CP-27IR-Heater Lamp Notes: Class II
Desc: Victoria Machine/cranial electro stimulator (modes; Gem zapper; cranial electro stimulator; colloidial silver; blood electrifier) Device Notes: Class II
Desc: Magnetic Pulser (1Amp Fuse; 110VAC) Device Notes: Class II
Desc: Ultimate Cancer Care (modes; zapper; sarcoma; carcinoma; colloidal silver) device and accessories; Notes: Class II
Desc: Electric massager (part 1 & 2; HIC - & HIC -); TDP CP-27IR-Heater Lamp Notes: Class II
Desc: Tri-Medica (modes; gem zapper; colloidial silver; blood electrifier) Notes: Class II
Notes: 6/29/ Oasis Cranial Electrotherapy Stimulator (CES)
Desc: Stimulator Electro-Acupuncture Notes: Class III
Desc: Mae Vaginal Suppository Notes: Class II device without a valid 510K
Desc: Mae Vaginal Suppository Notes: Class II device without a valid 510K
Desc: Mae Vaginal Suppository Notes: Class II device without a valid 510K
Desc: Mae Vaginal Suppository Notes: Class II device without a valid 510K
Desc: ECG Arrhythmia Simulator Model 10A and 20A Notes: Class II
Desc: ECG Arrhythmia Simulator Model 10A and 20A Notes: Class II
Desc: Angie Thermocoagulation System (Epilator) Notes: class II
Desc: Vitaderm System (Electric Therapeutic Massager) Notes: class II
Desc: Vitalift System (Electric Therapeutic Massager) Notes: class II
Desc: Vitalymph Pressotherapy System (Pressure Applying Device) Notes: class II
Desc: Vital-Ultra Anti-Cellulite System (Manual Therapeutic Massager) Notes: class II
Desc: Neck Comforter Notes: Class I
Desc: Neck Comforter Notes: Class I
Desc: CRT Thermographic System Notes: Class II
Desc: CRT Thermographic System Notes: Class II
Desc: CRT Thermographic System Notes: Class II
Desc: CRT Thermographic System Notes: Class II
Desc: Sonafon Sonic Acupuncture Notes: Class III
Notes: All devices. GPI = DE. 5/6/
Notes: All medical devices. GPI = DE, DI, BI, SD. 2/9/. The firm is known to have
shipped and/or marketed the following products in the US Rapid HIV Test Kit,
Class III device, Rapid Syphilis Test Kit, Class III Device, One Step Casette
Style Cocaine Test Kit, Class II device, One Step Cassette Style Marijuana THC
Test Kit, Class II device, One Step Cassette Style Amphetamine Test Kit, Class
II Device, Rapid Dangue Fever Test Kit Class III device, One Step Midstream
style HCG Urine Home Pregnancy Test Kit, Class III device. If districts
encounter shipments of any device from the above shipper/markerting firm,
contact DIOP attn Sammi Hadden 301-827-
Desc: Search N Stim Electronic Acupuncture Notes: Class III
Notes: All devices. GPI = DE. Wipeout Long Life Activated Dialehyde. 4/27/.
Notes: All devices. GPI = DE. Seasonal Affective Disorder Lights (SAD Lights) 2/4/
Notes: Class III; 3/5/09
Notes: Class III; 3/5/09
Desc: Scalar Energy Pendants Notes: Class II; 6/26/
Desc: Scalar Energy Pendants Notes: Class II; 6/26/
Notes: 11/9/. HIV 1/2 Blood Test Kit. HIV Diagnostic Kits are Class III
devices within the meaning of Section 513(f)(1) of the Act and are
regulated by CBER under the current intercenter agreement between
CDRH and CBER. The unapproved diagnostic test kits claim to detect
HIV antibodies in blood or saliva and provide results in the home in
15 minutes or less. The test kits are imported into the US through
the mail and may be entered as Asamples@ or for Apersonal usa@. The
contents may be labeled Afor investigational use@ for Aresearch use@
or Afor export only @. The test kits could present a serious hazard
to the public health; including possible HIV transmission to
partners and delayed access to medical care due to mis-diagnosed
false negative tests. If entries are encounted; contact CBER
Import/Export team at 301-827-.
Notes: 11/9/. HIV 1/2 Blood Test Kit. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Notes: LARS (Ligament Advanced Reinforcement System) 10/13/
Desc: The New Original Parasite Zapper Notes: Class II; 7/2/
Desc: The Original Parasite Zapper Notes: Class III; 7/2/
Desc: John's Only Pump Enlargement Pump Notes: Class II
Desc: John's Only Pump Enlargement Pump Notes: Class II
Desc: REVEALCOVID-19 %u Total Antibody Test
Desc: Teosyal Notes: Class III. Teosyal is a dermal filler intended for treating wrinkles; adding contour to facial features; enhancing the lips and eliminating the appearance of aging. The product is marketed on www.medicaoutlet.com.
Desc: Kaya17 nCoVega COVID-19 Antigen Test
Notes: All devices. DWI = DE. Seasonal Affective Disorder Lights (SAD Lights)
2/3/.
Desc: Andro Penis Extender Notes: Class II
Desc: Vimax System Notes: Class II
Desc: Vimax System Notes: Class II; 11/28/
Desc: Andro Penis Extender Notes: Class II
Desc: Matrix II; Bone Growth Stimulator
Desc: Matrix II; Bone Growth Stimulator
Desc: PES Detox System (foot bath)
Desc: PES Detox System (foot bath)
Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)
Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)
Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)
Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)
Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)
Notes: All devices. GPI = DE. Spinal Anethesia trays containing tetracaine
hydrochloride for use in the pediatric population. (3/5/ Continuous Spinal
Anethesia Trays non-pediatric) (7/30/ Epi-spinal Tray Re-Order # Epi
Spinal Mini Kit Reorder #)
Desc: Motion Relief Wrist Bands Notes: class II
Desc: Any Penile Corrective Devices Notes: Class III
Desc: Any Penile Corrective Devices Notes: Class III
Desc: Any Penile Corrective Devices Notes: Class III
Desc: Any Penile Corrective Devices Notes: Class III
Desc: RAMP COVID-19 Antigen Test
Desc: COVID-19 LFA
Desc: COVID-19 LFA
Notes: 10/26/. Discreet HIV Test. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: Lipomax RF Notes: clas II
Desc: Lumicell Wave Notes: class II
Desc: Lipomax RF Notes: class II
Desc: Lumicell Wave Notes: class II
Desc: Lumicell Wave Notes: class II
Desc: Lipomax RF Notes: class II
Desc: Lipomax RF Notes: class II
Desc: Lumicell Wave Notes: class II
Desc: Lumicell Wave Notes: class II
Desc: Lumicell Wave Notes: Class II
Desc: Lipomax RF Notes: Class II
Notes: 10/20/ Ground Zero; Ground System and method for organisms (Ground Zero Grounding Device)
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill
Notes: Decorative Contact Lenses. 4/7/.
Notes: Decorative Contact Lenses. 4/7/.
Notes: Decorative Contact Lenses. 4/7/.
Notes: Decorative Contact Lenses. 4/7/.
Notes: Decorative Contact Lenses. 4/7/.
Notes: Decorative Contact Lenses. 4/7/.
Notes: Decorative Contact Lenses. 4/7/.
Notes: Decorative Contact Lenses. 4/7/.
Notes: Decorative Contact Lenses. 4/7/.
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill.
Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill.
Notes: Contact lenses, all types. 2/9/
Desc: Neck Comforter Notes: Class I
Desc: Neck Comforter Notes: Class I
Desc: Neck Comforter Notes: Class I
Desc: Neck Comforter Notes: Class I
Desc: Safetest Covid-19 IgG/IgM Rapid Test
Desc: Any Penile Corrective Devices Notes: Class III
Desc: Any Penile Corrective Devices Notes: Class III
Notes: x4 Penile corrective device. 9/16/
Desc: Any Penile Corrective Devices Notes: Class III
Desc: X4 Penile corrective device Notes: 9/16/
Desc: Any Penile Corrective Devices Notes: Class III
Desc: iDream Head Massager Notes: CLASS; I/II
Desc: iDream Head Massager Notes: CLASS; I/II
Desc: iDream Head Massager Notes: CLASS; I/II
Desc: iDream Head Massager Notes: CLASS: I/II
Desc: nPLEX SARS-CoV-2 Detection Kit
Desc: SARS-CoV-2 IgG/IgM Antibody Test
Desc: SARS-CoV-2 IgG/IgM Antibody
Desc: Rapid COVID-19 Antigen Test (Colloidal Gold)
Desc: COVID-19 IgM/IgG Antibody Colloidal Gold Test
Desc: Rapid COVID-19 Antigen Test (Colloidal Gold)
Desc: Rapid COVID-19 Antigen Test (Colloidal Gold)
Desc: COVID-19 Capture ELISA Assay
Desc: COVID-19 Capture ELISA Assay
Desc: COVID-19 Capture ELISA Assay
Desc: Desensitizing Wand
Desc: Nocturns Anti-Glare Glasses Notes: class II
Desc: Nocturns Anti-Glare Glasses Notes: Class II
Desc: Nocturns Anti-Glare Glasses Notes: class II
Desc: Nocturns Anti-Glare Glasses Notes: class II
Desc: Nocturns Anti-Glare Glasses Notes: class II
Desc: Nocturns Anti-Glare Glasses Notes: class II
Desc: Mutation Detection Kit Notes: Class III
Desc: Mutation Detection Kit Notes: class III
Desc: Immune Colloidal Gold Lateral Flow Strip for IgG & IgM of SARS-CoV-2
Desc: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold)
Desc: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
Desc: Portable Smart Massage U Disc Tens Unit Notes: Class II
Desc: Rapid Response COVID-19 Antigen Rapid Test Device
Desc: NOVA COVID-19 IgG/IgM Antibody Rapid Test
Desc: NOVA COVID-19 IgG/IgM Antibody Rapid Test
Desc: NOVA COVID-19 IgG/IgM Antibody Rapid Test
Desc: Anti- SARS-COV-2 Rapid Test
Desc: Anti- SARS-COV-2 Rapid Test
Desc: Anti- SARS-COV-2 Rapid Test
Desc: -nCoV IgG Antibody Determination Kit
Desc: -nCoV IgM A
Desc: -nCOV IgG/IgM Antibody Rapid Test Kit
Desc: -nCOV IgG/IgM Antibody Rapid Test Kit
Desc: -nCoV IgG Antibody Determination Kit
Desc: -nCoV IgM A
Desc: -nCoV IgG Antibody Determination Kit
Desc: -nCoV IgM A
Desc: -nCOV IgG/IgM Antibody Rapid Test Kit
Desc: E Light (IPL RF) Beauty Equipment Notes: Class II
Desc: US309F Slimming Machine Notes: Class II/III
Desc: US309F Slimming Machine Notes: Class II/III
Desc: E Light (IPL RF) Beauty Equipment Notes: Class II
Desc: GL029 RF Cavitation Equipment Notes: Class; Unknown
Desc: GL029 RF Cavitation Equipment Notes: Class; Unknown
Desc: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Test
Desc: Novel Coronavirus - nCoV Antigen Test (Colloidal Gold)
Desc: Hair Removal Laser System
Desc: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit
Desc: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit
Desc: BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit
Desc: Heated Dry Eye Mask Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.
Desc: Heated Dry Eye Mask Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.
Desc: SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay)
Desc: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)
Desc: Hough Covid-19 Home Test
Desc: Qualitative Diagnostic Kit for Novel Coronavirus (-nCoV) IgG Antibody
Desc: Qualitative Diagnostic Kit for Novel Coronavirus (-nCoV) IgM Antibody
Desc: Qualitative Diagnostic Kit for Novel Coronavirus (-nCoV) IgG Antibody
Desc: Qualitative Diagnostic Kit for Novel Coronavirus (-nCoV) IgM Antibody
Desc: Diagnostic Kit for Novel Coronavirus (-nCoV) IgG Antibody
Desc: Novel Coronavirus (-nCoV) IgM/IgG Antibody Rapid Test
Desc: Diagnostic Kit for Novel Coronavirus (-nCoV) IgM Antibody
Desc: Qualitative Diagnostic Kit for Novel Coronavirus (-nCoV) IgG Antibody
Desc: Qualitative Diagnostic Kit for Novel Coronavirus (-nCoV) IgM Antibody
Desc: SARS-CoV-2 Antibody Test
Desc: -nCoV Antigen Test Kit (colloidal gold method)
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic) ;
Desc: PDT Machine
Desc: Beauty Machine
Desc: PDT Machine
Desc: Beauty Machine
Desc: 4S Beauty System Notes: Class II
Desc: 4S Beauty System Notes: Class II
Desc: 4S Beauty System Notes: Class II ;
Desc: 4S Beauty System Notes: Class II
Desc: 4S Beauty System Notes: Class II ;
Desc: 4S Beauty System Notes: Class II ;
Desc: 4S Beauty System Notes: Class II
Desc: 4S Beauty System Notes: Class II
Desc: 4S Beauty System Notes: Class II
Desc: -New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)
Desc: HIV Rapid Test
Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser) Notes: class 2
Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser) Notes: class 2
Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser) Notes: class 2
Desc: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)
Desc: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)
Desc: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)
Desc: Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit
Desc: Onsite HBsAG Rapid Test Cassette (Serum/Plasma) Kit
Desc: Led Photorejuvenation Device Notes: Class II
Desc: Led Photorejuvenation Device Notes: class II
Desc: Led Photorejuvenation Device Notes: class II
Desc: IPL SHR E-Light device
Desc: ETG50-4S Cryolipolysis System
Desc: Neck Comforter Notes: Class I
Desc: Neck Comforter Notes: Class I
Desc: NannoLight MP-50 Intense Pulsed Light and Laser System Notes: (includes a handpiece Long-Pulsed Nd;YAG laser); Class II; 9/1/
Notes: HIV 1 & 2 Rapid Test Kit 2/25/. HIV Diagnostic Kits are Class
III devices within the meaning of Section 513(f)(1) of the Act and
are regulated by CBER under the current intercenter agreement
between CDRH and CBER. The unapproved diagnostic test kits claim to
detect HIV antibodies in blood or saliva and provide results in the
home in 15 minutes or less. The test kits are imported into the US
through the mail and may be entered as Asamples@ or for Apersonal
usa@. The contents may be labeled Afor investigational use@ for
Aresearch use@ or Afor export only @. The test kits could present a
serious hazard to the public health; including possible HIV
transmission to partners and delayed access to medical care due to
mis-diagnosed false negative tests. If entries are encounted;
contact CBER Import/Export team at 301-827-.
Notes: HIV 1 & 2 Rapid Test Kit. 2/25/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: RF Rejuvenation Device Notes: Class II
Desc: RF Rejuvenation Device Notes: Class II
Desc: Disposable Virus Sampling Tube Kit- not inactivated
Desc: VTM Swab Sample Collection Tube Disposable Sampling Tube Kit (Shandong) -not inactivated
Desc: Disposable Virus Sampling Tube Kit- inactivated
Desc: VTM Swab Sample Collection Tube Disposable Sampling Tube Kit (Shandong) -Inactive
Desc: -nCoV RT-qPCR Detection Kit (Colloidal Gold)
Desc: Novel Coronavirus (-nCoV) Nucleic Acid Detection Kit (RT-PCR)
Desc: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Desc: G-421; G-425-1; G-425-3
Desc: Single Patient Use Aneroid Sphygmomanometer
Desc: Medic-Kit5 EMT Kit
Desc: COVIDEX-AB2
Desc: Biopolygen's COVID-19 Antibody Screening Test
Desc: COVIDEX-AB2
Desc: Biopolygen's COVID-19 Antibody Screening Test
Desc: Rebound Tonometer
Desc: UVC GERMICIDAL LIGHT UVFRESHR MINI
Desc: Single Patient Use Aneroid Sphygmomanometer
Desc: Medic-Kit5 EMT Kit
Desc: qSARS-CoV-2 IgG/IgM Rapid Test
Desc: Exa SARS- CoV-2 Rapid Antigen Test
Desc: Artemis System COVID-19 Antigen Rapid Test
Desc: Artemis Rapid Antigen Test Kit
Desc: qSARS-CoV-2 Antigen Rapid Test
Desc: COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)
Desc: nanoMedicina SARS-COV-2 IgM/IgG ANTIBODY RAPID TEST KIT
Desc: COVIDEX-AB2
Desc: COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)
Desc: Biopolygen's COVID-19 Antibody Screening Test
Desc: COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)
Desc: Nitrile Exam Gloves Powder Free Black
Desc: Nitrile Exam Gloves Powder Free Black
Notes: 11/30/ Universal Massage Apparatus
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: Product: Capillus 272 Laser Hair Cap
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Massager/Vibrator Notes: Class II
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: All models of patient monitors and their accessories
Desc: Coretests COVID-19 IgM/IgG Ab Test
Desc: COVID-19 IgM/IgG Ab Test
Desc: Pimple Remover Notes: Class II
Desc: UV Toothbrush Sanitizer Notes: Class II
Desc: UV Toothbrush Sanitizer Notes: Class II
Desc: UV Toothbrush Sanitizer Notes: Class II
Desc: UV Toothbrush Sanitizer Notes: Class II
Desc: UV Toothbrush Sanitizer Notes: Class II
Desc: UV Toothbrush Sanitizer Notes: Class II
Desc: Lumin LM Household Item Sanitizer and CPAP Accessory Cleaner Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.
Desc: Lumin LM Household Item UV Sanitizer Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.
Desc: Powder Free Nitrile Patient Examination Gloves Blue Color
Desc: Powder Free Blue Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
Desc: Portable Diamond Dermabrasion
Desc: Bipolar RF Skin Rejuvenation System
Desc: N95 Protective Mask
Desc: N95 Protective Mask
Desc: N95 Protective Mask
Desc: N95 Protective Mask
Desc: Powder Free Nitrile Patient Examination Gloves Blue Color
Desc: A-Vanguard Nitrile Examination Powder-Free Blue Gloves
Desc: Powder Free Blue Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
Desc: -nCoV IgG/IgM Rapid Test
Desc: RapidCOV IgM/IgG Antibody Test
Desc: SARS-CoV-2 IgM/IgG Antibody Test
Desc: Detection Kit for Novel Coronavirus (-nCoV) RNA (PCR-Fluorescence Probing)
Desc: Assurance AB COVID-19 IgM/IgG Rapid Antibody Test
Desc: DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT Notes: Class II device without a valid 510K
Desc: DENJOY DY400-6 ULTRAVIOLET LED CURING LIGHT Notes: Class II device without a valid 510K
Desc: ExtriCare Negative Pressure Wound Therapy Device
Desc: Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado) Notes: class II
Desc: Iriscope (Iriscopio) Notes: class II
Desc: Digital Blood Pressure Monitor (Arm & Writst) Notes: class II
Desc: Color Ray Beauty Light Therapy Device Notes: Class II
Desc: Color Ray Beauty Light Therapy Device Notes: Class II
Desc: Infrared Thermometer
Desc: Acupuncture Needles
Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)
Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)
Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)
Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)
Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)
Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)
Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)
Desc: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)
Desc: Multiple Electronic Acupunctoscope Notes: Class III
Desc: Smart Swab Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k).
Desc: Smart Swab Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k).
Desc: SARS-CoV-2 Antigen Test Kit
Desc: Covid 19 Antigen Self Test Kit
Desc: SARS-CoV-2 Antigen Test Kit
Desc: Covid 19 Antigen Self Test Kit
Desc: SARS-CoV-2 Antigen Test Kit
Desc: Covid 19 Antigen Self Test Kit
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: MC 600 Multi Function Anti Pressure Slimming Machine Notes: Device Classification Unknown. Some of the indications may be Class I exempt; some may fall under Class II requiring 510(k) notification; some may not have a predicate and may require de novo or PMA. Submission of a 513(g) is recommended so the closest classification can be determined. ; 5/24/
Desc: Massager Notes: Class II
Desc: Massager Notes: Class II
Desc: Massager Notes: Class II
Desc: Massager Notes: Class II
Desc: Portable High Frequency Spot Remover; JX-006A Massager Notes: Class II/III
Desc: Portable High Frequency Spot Remover; JX-006A Massager Notes: class II/III
Desc: Portable High Frequency Spot Remover; JX-006A Massager Notes: Class II/III
Notes: 6/5/ "Perfectha Derm" Hyaluronic Acid for cosmetic injection.
Desc: "Drug Abuse Test" IVD kit
Desc: Bodycomfort EMS Abs and Arms Notes: Class II
Desc: Bodycomfort EMS Abs and Arms Notes: class II
Desc: Bodycomfort EMS Abs and Arms Notes: class II
Desc: Novel Coronavirus (-nCoV) Nucleic Acid Detection Kit (RT-PCR)
Desc: -nCoV IgM/IgG
Desc: Novel Coronavirus (- nCoV)IgG/IgMTest Kit(Colloidal gold)
Desc: Nitrile Gloves
Desc: Nitrile Gloves
Desc: SARS-CoV-2 IgG/IgM Kit
Desc: SARS-CoV-2 IgG/IgM Kit
Desc: SARS-CoV-2 IgG/IgM Kit
Desc: LED Skin Conditioning Kit Compact Light Therapy Notes: Class II
Desc: LED Skin Conditioning Kit Compact Light Therapy Notes: Class II
Desc: LED Skin Conditioning Kit Compact Light Therapy Notes: Class II
Desc: LED Skin Conditioning Kit Compact Light Therapy Notes: Class II
Desc: SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound Notes: Class II
Desc: Mole Removal Pen
Desc: Hydra Roller
Desc: Microneedle
Desc: Hydra Pen
Desc: Meso Pen
Desc: Microneedle Pen
Desc: Hydra Needle
Desc: Derma Pen
Desc: Hydra Needle
Desc: Derma Pen
Desc: Meso Pen
Desc: Microneedle Pen
Desc: Hydra Roller
Desc: Hydra Pen
Desc: Microneedle
Desc: Hydra Roller
Desc: Meso Pen
Desc: Hydra Needle
Desc: Derma Pen
Desc: Microneedle
Desc: Hydra Pen
Desc: Microneedle Pen
Desc: Derma Pen
Desc: Microneedle
Desc: Meso Pen
Desc: Microneedle Pen
Desc: Hydra Pen
Desc: Hydra Needle
Desc: Hydra Roller
Desc: Microneedle
Desc: Meso Pen
Desc: Hydra Roller
Desc: Derma Pen
Desc: Microneedle Pen
Desc: Hydra Needle
Desc: Hydra Pen
Desc: Microneedle Pen
Desc: Meso Pen
Desc: Hydra Roller
Desc: Hydra Pen
Desc: Derma Pen
Desc: Hydra Needle
Desc: Microneedle
Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit
Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit
Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit
Desc: Colorful LED Beauty Mask Notes: Class II device without a valid 510K
Desc: Colorful LED Beauty Mask Notes: Class II device without a valid 510K
Desc: Colorful LED Beauty Mask Notes: Class II device without a valid 510K
Desc: 8D HIFU Home Use Massager
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine Notes: Class II
Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine Notes: Class II
Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine Notes: Class II
Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine Notes: Class II
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System Notes: Class II
Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine Notes: Class II
Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine Notes: Class II
Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System Notes: Class II
Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine Notes: Class II
Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine Notes: Class II
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System Notes: Class II
Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine Notes: Class II
Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine Notes: Class II
Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine Notes: Class II
Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine Notes: Class II
Desc: Facial Beauty Machine Notes: Class II; 4/5/
Desc: SYL-08XLTB; 5.1 in 1 Mult-Function Microdermabrasion Machine Notes: Class II
Desc: SYL-60 (NV-60); Diamond Dermabrasion Machine Notes: Class II
Desc: SYL-64X; 3 in 1 Vacuum and Spray Diamond Microdermabrasion Machine Notes: Class II
Desc: SYL-09XLT; 6.1 in 1 Diamond Microdermabrasion Machine Notes: Class II
Desc: SYL-08XLT; 4 IN 1 Diamond Dermabrasion System Notes: Class II
Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT
Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT
Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT
Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT
Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT
Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT
Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT
Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT
Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT
Desc: OXYGENATING INFUSION Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: LIGHT FREQUENCY THERAPY Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: LIGHT FREQUENCY THERAPY Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: RADIOFREQUENCY STIMULATION Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: DERMAL NEEDLING ENHANCER Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert
Desc: Rebound Tonometer
Desc: Pulse Generator; Pacemaker Implantable Notes: Class III; 4/14/
Desc: Pregnancy Test Kits
Desc: Novel Coronavirus (-nCoV) Nucleic Acid Detection Kit (RT-PCR)
Desc: -nCoV IgM/IgG
Desc: Novel Coronavirus(-nCoV)IgG/IgM Test Kit(Colloidal gold)
Desc: One Step Test for Novel Coronavirus (-nCoV) IgM/IgG antibody (Colloidal Gold)
Desc: One Step Test for Novel Coronavirus (-nCoV) IgM/IgG antibody (Colloidal Gold)
Desc: One Step Test for Novel Coronavirus (-nCoV) IgM/IgG antibody (Colloidal Gold)
Desc: Clean Safety Biodegradable Clear Vinyl Examination Gloves
Desc: Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit(PCR fluorescent Probe)
Desc: Disposable sterile needle retractable safety syringe 1mL 25G x 1inch (25mm) Notes: Needle Retractable Safety Syringe; model 1mL 25G x 1inch (25mm) dimensions subject to DWPE
Desc: Disposable sterile needle retractable safety syringe 1mL 23G x 1inch (25mm) Notes: Needle Retractable Safety Syringe; model 1mL 23G x 1inch (25mm) dimensions subject to DWPE
Desc: Nitrile Gloves
Desc: Nitrile Gloves
Desc: Nitrile Gloves
Desc: Condoms Notes: Class II
Desc: Condoms Notes: Class II
Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber Notes: For over the counter (OTC) use
Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin Notes: For over the counter (OTC) use
Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin Notes: For over the counter (OTC) use
Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber Notes: For over the counter (OTC) use
Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber Notes: For over the counter (OTC) use
Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin Notes: For over the counter (OTC) use
Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin Notes: For over the counter (OTC) use
Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber Notes: For over the counter (OTC) use
Desc: Laser Lipolysis device Notes: class II
Desc: Laser Lipolysis device Notes: class II
Desc: Laser Lipolysis device Notes: Class II
Desc: Laser Lipolysis device Notes: class II
Desc: Massage Ultrasound Equipment Notes: Class III ;
Desc: Therapeutic Skin Ultrasound Devices Notes: Class III ;
Desc: Massage Ultrasound Equipment Notes: Class III
Desc: Massage Ultrasound Equipment Notes: Class III
Desc: Therapeutic Skin Ultrasound Devices Notes: Class III
Desc: Scalar Energy Pendants Notes: Class II
Desc: Scalar Energy Pendants Notes: Class II
Desc: Rebound Tonometer
Desc: Probe Cover; ultrasound Notes: Class II device without a valid 501K. For PC 80MMP; only ultrasound probe covers are subject to DWPE under this listing.
Desc: Probe Cover; ultrasound Notes: Class II device without a valid 501K.
Desc: Electrostatic Field Therapy Device Notes: Class II
Desc: Electrostatic Field Therapy Device Notes: Class II
Desc: Electrostatic Field Therapy Device Notes: Class II
Desc: Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices Notes: 2/24/
Desc: Skin Scrubber Beauty Machine Notes: class II
Desc: Skin Scrubber Beauty Machine Notes: class II
Desc: Skin Scrubber Beauty Machine Notes: Class II
Desc: Micro Needle Skin Roller Notes: class II
Desc: Skin Resurfacer
Desc: Skin Resurfacer
Desc: Skin Resurfacer
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Notes: All device products; Class I, II, III
Desc: Micro Needle Roller Notes: Class II
Desc: Micro Needle Roller Notes: Class II
Desc: Cold Pack and Vibrating Massager
Desc: Cold Pack and Vibrating Massager
Desc: Cold Pack and Vibrating Massager
Desc: Cold Pack and Vibrating Massager
Desc: Cold Pack and Vibrating Massager
Desc: Cold Pack and Vibrating Massager
Desc: Tanning Bed
Desc: Dr. Fargo Photon Energy Detoxification Bag Notes: Class II Device (may be a Class III). The device claims made are varied and the mechanism of technology of the device is and it is unclear how the device produces the intended effects are unclear. CDRH is not aware of any predicate devices that the manufacturer may compare to for 510(k) submission. Therefore; there is no specific product code or regulation that applies to this device since there are no known predicate device(s).
Desc: Body Relaxing Machine (weight loss device) Notes: Class II
Desc: Body Relaxing Machine (weight loss device) Notes: Class II
Desc: Body Relaxing Machine (weight loss device) Notes: Class II
Desc: Body Relaxing Machine (weight loss device) Notes: Class II
Desc: Detoxification Food Spa
Desc: Derma (Body) Roller Notes: Class II Device
Desc: Derma (Body) Roller Notes: Class II Device
Desc: Derma (Body) Roller Notes: CLASS II Device
Desc: Derma (Body) Roller Notes: Class II Device
Desc: Wondfo SARSCoV-2 Antibody Test (Lateral Flow Method
Desc: OTESALY Cross-linked Hyaluronic Acid w/lidocaine Notes: Class III device without a premarket approval (PMA)
Desc: OTESALY Cross-linked Hyaluronic Acid w/lidocaine Notes: Class III device without a premarket approval (PMA)
Desc: Derma Stamp Electric Pen Notes: Class II
Desc: Derma Stamp Electric Pen Notes: Class II
Desc: Derma Stamp Electric Pen Notes: class II
Desc: Manual Therapeutic Massager
Desc: Manual Therapeutic Massager Notes: Class III
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Notes: All Devices; Class II
Desc: Microneedle roller Notes: class III
Desc: Microneedle roller Notes: Class III
Desc: QuickKit Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold Method)
Desc: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)
Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device
Desc: nCOV IgG/IgM Rapid Test
Desc: Realy New Coronavirus Covid19 Rapid test
Desc: Realy New Coronavirus Covid19 Rapid test
Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device
Desc: nCOV IgG/IgM Rapid Test
Desc: nCOV IgG/IgM Rapid Test
Desc: Realy New Coronavirus Covid19 Rapid test
Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device
Desc: Realy New Coronavirus Covid19 Rapid test
Desc: nCOV IgG/IgM Rapid Test
Desc: Anti SARS CoV 2 IgG/IgM Rapid Test Device
Desc: One Step SARS-CoV2(COVID-19) IgG/IgM Test
Desc: One Step SARS-CoV2(COVID-19) IgG/IgM Test
Desc: TESTSEALABS Covid-19 IgG/IgM Rapid Test Kit
Desc: SARS-CoV-2 IgG/IgM Test Cassette
Desc: One Step SARS-CoV2(COVID-19) IgG/IgM Test
Desc: QuickZen COVID-19 IgM / IgG
Desc: QuickZen COVID-19 IgM / IgG
Desc: Adhesive tape
Desc: Adhesive tape
Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
Desc: New Coronavirus COVID-19 Nucleic Acid Dectection Kit (Fluorescent RT-PCR- Method)
Desc: Magnetic Acupressure Suction Cup
Desc: Disposable Virus Specimen Collection Tube
Desc: Viral Transport Tube; Type HX-K59; HX-K60; HX-K61
Desc: Viral Transport Media; Type HX-K59; HX-K60; HX-K61
Desc: Viral Transport Tube; Type HX-K59; HX-K60; HX-K61
Desc: Viral Transport Media; Type HX-K59; HX-K60; HX-K61
Desc: Viral Transport Tube; Type HX-K59; HX-K60; HX-K61
Desc: Virus Collection Tube Kit
Desc: COVID IgG/IgM Rapid Test Strip
Desc: -NCOV IGG/IGM RAPID TEST CASSETTE
Desc: HIV test kit Notes: class II
Desc: NADAL COVID-19 IgG/IgM Test
Desc: COMBRA COVID-19 IgM/IgG Rapid Test Cassette
Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette
Desc: COMBRA COVID-19 IgM/IgG Rapid Test Cassette
Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette
Desc: COMBRA COVID-19 IgM/IgG Rapid Test Cassette
Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette
Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette
Desc: CLUNGENE COVID-19 IgG/IgM Rapid Test Kit
Desc: CLUNGENE SARSCOV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette
Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette
Desc: Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette
Desc: KaiBiLi COVID-19 Antigen Rapid Test Device
Desc: AntiCHEK SARS-CoV-2 (COVID-19) Rapid Antigen Test
Desc: Singfiller Cross-linked Sodium Hyaluronate Gel Notes: Class III device without a PMA
Desc: Singfiller Cross-linked Sodium Hyaluronate Gel Notes: Class III device without a PMA
Desc: SINGFILLER ANTI-AGING GEL Notes: Class III device without a PMA
Desc: Singfiller Cross-linked Sodium Hyaluronate Gel Notes: Class III device without a PMA
Desc: SINGFILLER ANTI-AGING GEL Notes: Class III device without a PMA
Desc: Singfiller Cross-linked Sodium Hyaluronate Gel Notes: Class III device without a PMA
Notes: 2/16/ HIV Self Test Kit HIV Diagnostic Kits are Class III
devices within the meaning of Section 513(f)(1) of the Act and are
regulated by CBER under the current intercenter agreement between
CDRH and CBER. The unapproved diagnostic test kits claim to detect
HIV antibodies in blood or saliva and provide results in the home in
15 minutes or less. The test kits are imported into the US through
the mail and may be entered as Asamples@ or for Apersonal usa@. The
contents may be labeled Afor investigational use@ for Aresearch use@
or Afor export only @. The test kits could present a serious hazard
to the public health; including possible HIV transmission to
partners and delayed access to medical care due to mis-diagnosed
false negative tests. If entries are encounted; contact CBER
Import/Export team at 301-827-.
Notes: 2/16/ HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Electric TENS massager Notes: class II
Desc: Quartz Crystal Pens
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon ;
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon
Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic) ;
Desc: Digital Therapy Machine Tens Unit Notes: Class II
Notes: 4/20/ Health Builder
Notes: Hothouse FIR Health Builder 11/26/
Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
Desc: COVID-19 Antigen
Desc: Scanwell SARS-CoV-2 IgM & IgG Test System
Desc: Innovita -nCoV Ag Test (Latex Chromatography Assay)
Desc: HIV Home Test Kit Notes: Class III
Desc: SARS-CoV-2 & Influenza A/B Nucleic Acid Test
Desc: EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
Desc: EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
Desc: EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
Desc: SARS-CoV-2 IgG/IgM Rapid Assay Kit (Colloidal Gold)
Desc: Virus Transport Kit
Desc: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
Desc: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab)
Desc: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
Desc: EasyRapidNow COVID-19 Nasal Swab Antigen Test
Desc: EasyRapidNow COVID-19 Antigen Test/Kit
Desc: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab)
Desc: EasyRapidNow COVID-19 Nasal Swab Antigen Test
Desc: EasyRapidNow COVID-19 Antigen Test/Kit
Desc: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
Desc: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
Desc: Hyaluronic Acid Gel Notes: Class III. Hyaluronic Acid Gel is a dermal filler marketed for the treatment of wrinkles and for buttocks and breast augmentation. Product is marketed on www.BeautyCosmeticStore.com.
Desc: Snore Strip Notes: 3/9/
Desc: COVID-19 IgM-IgG Rapid Test
Desc: BioMedomics COVID-19 IgG Rapid Test
Desc: BioMedomics Gen3 COVID-19 IgM-IgG Rapid Test
Desc: BioMedomics CoV-SCAN Rapid Antigen Test
Desc: COVID-19 IgM-IgG Rapid Test
Desc: BioMedomics COVID-19 IgG Rapid Test
Desc: BioMedomics Gen3 COVID-19 IgM-IgG Rapid Test
Desc: BioMedomics CoV-SCAN Rapid Antigen Test
Desc: All Syringes
Desc: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
Desc: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
Desc: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
Desc: Portable Electric Steam Sterilizer (Model SYL-280B) Notes: Class II
Desc: Poly L-Lactic Acid
Desc: Powdered Free Vinyl Patient Examination
Gloves Light Yellow Color Notes: <<>>
Desc: Vibration Plate Notes: Ultra-Thin Body Slimmer
Desc: Novir Insta COVID-19 Antibody Test
Desc: Novir COVID-19 SARS-CoV2 IgM/IgG Antibody rapid test
Desc: Novir COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)
Desc: Novir Insta COVID-19 Antibody Test
Desc: Novir COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)
Desc: Novir COVID-19 SARS-CoV2 IgM/IgG Antibody rapid test
Desc: E Light Intense Pulsed Light Beauty Equipment Notes: Class II
Desc: Crystal Fat Deflagration Equipment Notes: Class II
Desc: Crystal Fat Deflagration Equipment Notes: Class II
Desc: E Light Intense Pulsed Light Beauty Equipment Notes: Class II
Desc: Exerciser; Powered Notes: Power Vibe Whole Body Vibration Machine (WBV), Home Pro 2, Class II
Desc: SARS-CoV-2 Real-TM
Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR)
Desc: AccuraDTect SARS-CoV-2 RT-qPCR Kit
Desc: StrongStep SARS-CoV-2 lgM/IgG Antibody Rapid Test
Desc: StrongStep System Device for SARS-CoV2 Antigen Rapid Test
Desc: SARS-CoV2 Antigen Rapid Test
Desc: FACIAL MASSAGER FOR PERSONAL USE Notes: class II
Desc: Covid Test
Desc: SARS COV 2 Antigen Rapid Test
Desc: Corona Virus Test Kit
Desc: Corona Virus Reagent Kit
Desc: SARS COV2 Antibody Test Colloidal Gold Immunochromatography
Desc: SARS-COV-2 ANTIBODY TEST
Desc: Lepu Antigen Test
Desc: Bt-Micro Dermabrasion Unit Notes: Class II
Desc: Bt-Micro Dermabrasion Unit Notes: class II
Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove
Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove
Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove
Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove
Desc: Nitra Med HEAVY Powder Free Nitrile Examination Glove
Desc: Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05
Desc: Viral Transport Media With Guanidine Hydrochloride And Isothiocyanate; models MTM-01; MTM-02; MTM-03; MTM-04; MTM-05
Desc: LBS11 RF Skin Lift Notes: Class II
Desc: Lbs56 Lipolaser Notes: Class II
Desc: Panda B; RF Beauty Notes: Class II
Desc: Lipolaser Machine Notes: Class II
Desc: Lbs54 lipo Laser Fat Burning Notes: Class II
Desc: Lbs12 Vertical RF Notes: class II
Desc: Panda B; RF Beauty Notes: Class II
Desc: Lipolaser Machine Notes: Class II
Desc: LBS11 RF Skin Lift Notes: Class II
Desc: Lbs12 Vertical RF Notes: class II
Desc: Lbs56 Lipolaser Notes: Class II
Desc: Lbs54 lipo Laser Fat Burning Notes: Class II
Desc: Lipolaser Machine Notes: Class II
Desc: Lbs54 lipo Laser Fat Burning Notes: Class II
Desc: Lbs12 Vertical RF Notes: class II
Desc: Lbs56 Lipolaser Notes: Class II
Desc: LBS11 RF Skin Lift Notes: Class II
Desc: Panda B; RF Beauty Notes: Class II
Desc: LBS11 RF Skin Lift Notes: Class II
Desc: Lbs54 lipo Laser Fat Burning Notes: Class II
Desc: Lipolaser Machine Notes: Class II
Desc: Lbs12 Vertical RF Notes: class II
Desc: Panda B; RF Beauty Notes: Class II
Desc: Lbs56 Lipolaser Notes: Class II
Desc: Lbs54 lipo Laser Fat Burning Notes: Class II
Desc: LBS11 RF Skin Lift Notes: Class II
Desc: Lipolaser Machine Notes: Class II
Desc: Panda B; RF Beauty Notes: Class II
Desc: Lbs56 Lipolaser Notes: Class II
Desc: Lbs12 Vertical RF Notes: class II
Desc: Lbs12 Vertical RF Notes: class II
Desc: LBS11 RF Skin Lift Notes: Class II
Desc: Panda B; RF Beauty Notes: Class II
Desc: Lbs54 lipo Laser Fat Burning Notes: Class II
Desc: Lbs56 Lipolaser Notes: Class II
Desc: Lipolaser Machine Notes: Class II
Desc: Surgical Mask Notes: Class II
Desc: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
Desc: SARS-CoV-2 Antigen Rapid Test Cassette
Desc: Coronavirus Disease Antibody (IgM/IgG) Combined Test Kit
Desc: Coronavirus Disease Antibody (IgM/IgG) Combined Test Kit
Desc: Coronavirus Disease Antibody (IgM/IgG) Combined Test Kit
Desc: Coronavirus Disease Antibody (IgM/IgG) Combined Test Kit
Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application
Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application
Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application
Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application
Desc: All IVD Tests Notes: 11/14/;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test
Kits are not subject to DWPE
Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits
are not subject to DWPE
Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits
are not subject to DWPE
Desc: Personal Slimming Machine Notes: Class III
Desc: Executive Ion Detox Machine (TENS Unit; Far Infrared Belt; and Ion Detox) Notes: Class II
Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application
Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application
Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application
Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application
Desc: Laser Lipolysis Device Notes: class II
Desc: Laser Lipolysis Device Notes: class II
Desc: Laser Lipolysis Device Notes: class II
Desc: Laser Lipolysis Device Notes: Class II
Desc: Laser Lipolysis Device Notes: class II
Desc: Hair Steamer Notes: Class II
Desc: Beauty Instruments Notes: Note; Product may be declared under Model M and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II
Desc: Beauty Instruments Notes: Note; Product may be declared under Model M and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II
Desc: Beauty Instruments Notes: Note; Product may be declared under Model M and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II
Desc: Beauty Instruments Notes: Note; Product may be declared under Model M and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II
Desc: Beauty Instruments Notes: Note; Product may be declared under Model M and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II
Desc: Beauty Instruments Notes: Note; Product may be declared under Model M and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II
Desc: Vaporizer Notes: Class II
Desc: Facial Brush and Vacuum Notes: Class II
Desc: Beauty Instruments Notes: Note; Product may be declared under Model M and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II
Desc: Massage Hammer Notes: Class II
Desc: Cosmetic Vibrator Notes: Class II
Desc: Beauty Instruments Notes: Note; Product may be declared under Model M and/or 13 in 1 Beauty Instrument. None have clearance; Class I/II
Desc: Rebound Tonometer
Desc: -nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)
Desc: -nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)
Desc: -nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)
Desc: Rebound Tonometer
Desc: AEROLUX POWERED WHEELCHAIR
Desc: Massager Notes: Rhino Roller; Class II
Desc: Novel Coronavirus (-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)
Desc: Novel Coronavirus (-nCOV) Antigen Testing Kit (Colloidal Gold)
Desc: Massager Notes: Rhino Roller; Class II
Desc: EGENS COVID-19 IgG/IgM Rapid Test Kit
Desc: EGENS COVID-19 IgG/IgM Rapid Test Kit
Desc: EGENS COVID-19 IgG/IgM Rapid Test Kit
Desc: Skin permeation enhancer beauty pens Notes: Class II
Desc: Rebound Tonometer
Desc: Mi.Sens SAA/CRP/IgM/IgG Cov-19 Microfluidic Rapid Test System
Desc: COVID-19 Microfluidic Combo Test
Desc: BellaBaby Hands Free Electric Breast Pump (BLA/BLA-2)
Desc: Rebound Tonometer
Desc: Radio Frequency Skin Lifting device Notes: Class II
Desc: Radio Frequency Skin Lifting device Notes: Class II
Desc: Dental X Ray Machine Notes: Class II
Desc: Dental X Ray Machine Notes: Class II
Desc: Oximeter
Desc: Plastic Cupping Set Breast Enlargement Cup Notes: Class II
Desc: Plastic Cupping Set Breast Enlargement Cup Notes: class II
Desc: Plastic Cupping Set Breast Enlargement Cup Notes: class II
Desc: Impulse Ion Notes: Class II
Desc: Impulse Ion Notes: Class II
Desc: Impulse Ion Notes: Class II
Desc: GS8.0 Cavitation Machine Notes: Class II
Desc: GRF-11 Monopolor Radio Frequency machine Notes: Class II
Desc: GS8.0 Cavitation Machine Notes: Class II
Desc: GRF-11 Monopolor Radio Frequency machine Notes: Class II
Notes: 7/9/ Body Massage Kits.
Desc: Ear Cleaning Tool Notes: For over the counter (OTC) use
Desc: Ear Cleaning Tool Notes: For over the counter (OTC) use
Desc: SARS-CoV-2 Antibody Detection Kit
Desc: SARS-CoV-2 Antibody Detection Kit
Desc: SARS-CoV-2 Antibody Detection Kit
Desc: SARS-CoV-2 Antibody Detection Kit
Desc: Digital Ultrasound Scanner Notes: Class II
Desc: Digital Ultrasound Scanner Notes: Class II
Desc: Rhythm Tough Ultra (Nerve/Muscle Stimulator)
Desc: Rhythm Tough Ultra (Nerve/Muscle Stimulator)
Desc: SARS-CoV-2 IgM/IgG Antibody Rapid Test
Desc: COVID-19 IgM/IgG Rapid Test Kit
Desc: COVID-19 IgM & IgG Rapid Test Kit
Desc: COVID-19 IgM & IgG Rapid Test Kit
Desc: COVID-19 IgM/IgG Rapid Test Kit
Desc: Biolift Beauty Machine Notes: class II
Desc: Biolift Beauty Machine Notes: Class II
Desc: Biolift Beauty Machine Notes: class II
Desc: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)
Desc: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)
Desc: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)
Desc: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)
Desc: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)
Desc: QXD-3 COVIDNOW
Desc: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)
Desc: Magic Masseuse (Electronic Stimulation Massage unit) Notes: Class II
Desc: Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma)
Desc: COVID-19 IgG/IgM Rapid Test Device
Desc: SAFECARE nCoV IgG/IgM Rapid Test
Desc: Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma)
Desc: SAFECARE nCoV IgG/IgM Rapid Test
Desc: COVID-19 IgG/IgM Rapid Test Device
Desc: COVID-19 IgG/IgM Rapid Test Device
Desc: Covid-19 IgG/IgM Rapid Test (Whole Blood Plasma)
Desc: SAFECARE nCoV IgG/IgM Rapid Test
Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves
Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves
Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves
Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves
Desc: Powder-Free Nitrile Patient Examination Gloves Blue Color
Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves
Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves
Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves
Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves
Desc: Cavitation and Radio Frequency Slimming Machine HM-800
Desc: Cavitation and Radio Frequency Slimming Machine HM-800
Notes: Shipper for Guanzhou NuhNan Shandong Medicines and Health Products. Positive/Negative Integrated Computer Control Augmented Sequential External Counter-Pulsation Device.
Desc: Disinfectant Machine
Desc: Powder-Free Nitrile Patient Examination Gloves
Desc: -nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay)
Desc: Hyperbaric Chamber
Desc: Hyperbaric Chamber
Desc: Hyperbaric Chamber
Desc: Rebound Tonometer
Desc: Chemtrue COVID-19 IgM/IgG Antibody Rapid Test
Desc: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit
Desc: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit
Desc: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit
Desc: Liangrun COVID-19 IgM/IgG Antibody Test
Desc: Diagnostic Kit for Detection of COVID-19 Antibodies (IgG/IgM)
Desc: Liangrun COVID-19 IgM/IgG Antibody Test
Desc: Liangrun COVID-19 IgM/IgG Antibody Test
Desc: Liangrun COVID-19 IgM/IgG Antibody Test
Desc: H8 Shockwave Massage Machine Notes: Class I device without a valid 510K
Desc: H8 Shockwave Massage Machine Notes: Class I device without a valid 510K
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Rebound Tonometer
Desc: Microneedle Face Roller System
Desc: Electric Microneedle Derma Pen System
Desc: Electric Microneedle Derma Pen System
Desc: Microneedle Face Roller System
Desc: Synergy Neck Massager Model BP-
Desc: Synergy Neck Massager Model BP-
Desc: PowerUp Penis Pump
Desc: Massager Notes: Class II
Desc: Massager Notes: Class II
Desc: Massager Notes: Class II;
4/18/
Desc: Massager Notes: Class II
Desc: AVCOO TENS/EMS Model AS
Desc: AVCOO TENS/EMS Model AS
Desc: Quantum Cuppergini Massager with Red Light Technology
Desc: Quantum Cuppergini Massager with Red Light Technology
Desc: Hair Removal Handset
Desc: Hair Removal Handset
Desc: True-Dot Novel Coronavirus (-nCoV) IgM/IgG rapid antibody detection kit
Desc: COVID-19 IgG/IgM RAPID TEST
Desc: Novel Coronavirus (-nCoV) Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)
Desc: COVID-19 IgG/IgM RAPID TEST
Desc: COVID-19 IgG/IgM RAPID TEST
Desc: Green Spring USA COVID-19 (-nCoV) Coronavirus IgG/IgM Rapid Test Kit
Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method
Desc: Green Spring COVID-19 IgG/IgM Rapid Test
Desc: COVID-19 (-nCoV) Coronavirus IgG/IgM Rapid Test Kit
Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method
Desc: Green Spring USA COVID-19 (-nCoV) Coronavirus IgG/IgM Rapid Test Kit
Desc: COVID-19 (-nCoV) Coronavirus IgG/IgM Rapid Test Kit
Desc: Green Spring COVID-19 IgG/IgM Rapid Test
Desc: COVID-19 (-nCoV) Coronavirus IgG/IgM Rapid Test Kit
Desc: Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method
Desc: Green Spring COVID-19 IgG/IgM Rapid Test
Desc: Green Spring COVID-19 IgG/IgM Rapid Test
Desc: COVID-19 (-nCoV) Coronavirus IgG/IgM Rapid Test Kit
Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method
Desc: Lipolysis Laser Notes: Class II
Desc: Lipolysis Laser Notes: Class II
Desc: Diazyme SARS-CoV-2 Neutralizing Antibody CLIA kit
Desc: Portable High Frequency Spot Remover; Electric Facial Cleansing Brush
Desc: Portable High Frequency Spot Remover; Electric Facial Cleansing Brush
Desc: Portable High Frequency Spot Remover; Electric Facial Cleansing Brush
Desc: Diode Laser Hair Removal Machine
Desc: Diode Laser Hair Removal Machine
Desc: Renpho Leg Compression Massager
Desc: Leg Massager
Desc: Renpho Leg Massager
Desc: Renpho Leg Massager
Desc: Leg Massager
Desc: Renpho Leg Compression Massager
Desc: Body Massager Notes: Class I device; requires 510(k)
Desc: Cupping Therapy Set Notes: Class I device; requires 510(k)
Desc: Cupping Therapy Set Notes: Class I device; requires 510(k)
Desc: Disposable SpO2 sensor (oximeter) Neonatal (<3kg)
Desc: Neck Lift Premium Device
Desc: Neck LED Spectrum Device
Desc: Facial Multi Therapy Device
Desc: LED MICRO-FACIAL MASSAGER
Desc: LED MICRO-FACIAL MASSAGER
Desc: LED MICRO-FACIAL MASSAGER
Desc: LED MICRO-FACIAL MASSAGER
Desc: LED MICRO-FACIAL MASSAGER
Desc: LED MICRO-FACIAL MASSAGER
Desc: SARS-CoV-2 IgG & IgM Ab Test Kit (Colloidal Gold)
Desc: COVID-19 IgG/IgM Detection Kit (Colloidal Gold)
Desc: Singuway COVID-19 Test Kit
Desc: SARS-CoV-2 Antibody Test Strip
Desc: SARS-CoV-2 Antibody Test Strip
Desc: SARS-CoV-2 Antibody Test Strip
Desc: SARS-CoV-2 Antibody Test Strip
Desc: Floatation Capsule Notes: Device Classification unknown.
Desc: Rebound Tonometer
Desc: RedLife Therapy lamp; Red Light Therapy; Model RT500
Desc: API Covid-Rapid IgM/IgG Antibody Test Kit
Desc: Covid-Rapid SARS-CoV-2 IgM/IgG AB (WB/S/P)
Desc: API Covid-Rapid IgM/IgG Antibody Test Kit
Desc: API Pharma Covid-Rapid IgM/IgG Antibody Test
Desc: API Covid-Rapid IgM/IgG Antibody Test Kit
Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette
Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette
Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette
Desc: FastPlex Triplex SARS-CoV-2 Detection Kit (RT- PCR)
Desc: Facial Massager Machine; Ulthera System Notes: Class II device without a valid 510K ;
Desc: Facial Massager Machine; Ulthera System Notes: Class II device without a valid 510K ;
Desc: Facial Massager Machine; Ulthera System Notes: Class II device without a valid 510K
Desc: HIFU Ultrasonic Skin Lift (Beauty Machine) Notes: Class II device without a valid 510K
Desc: HIFU Ultrasonic Skin Lift (Beauty Machine) Notes: Class II device without a valid 510K
Desc: HIFU Ultrasonic Skin Lift (Beauty Machine) Notes: Class II device without a valid 510K
Desc: Air Pressure Body Slimming Suit Notes: Class II device
Desc: ReBuilder 300 System; ReBuilder Personal System Notes: Class II
Desc: ReBuilder 300 System; ReBuilder Personal System Notes: Class II
Desc: ReBuilder 300 System; ReBuilder Personal System Notes: Class II
Desc: ReBuilder 300 System; ReBuilder Personal System Notes: Class II
Desc: Disposable Virus Specimen Collection Tube
Desc: Viral transport media Viral transport tube
Desc: Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04
Desc: Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04
Desc: Nitrile Examination Gloves Powder Free (White)
Desc: Black Nitrile Powder Free Exam Gloves
Desc: Rebound Tonometer
Desc: Foot Massager
Desc: Foot Massager
Desc: Derma Needle Roller Notes: Class I device without a valid 510k
Desc: Derma Needle Roller Notes: Class I device without a valid 510k
Desc: Respirators Surgical
Desc: Respirators Surgical
Desc: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
Desc: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
Desc: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
Desc: Smart-Wave; Acoustic Wave System Notes: Class I device without a valid 510K
Desc: Face Mask Notes: Device Classification is unknown
Desc: Kindmax Therapy Tape Notes: class 2
Desc: Precut Kinesiology Tape (Calf & Achilles Support; Foot Support)
Desc: Kindmax Therapy Tape Notes: class 2
Desc: Kindmax Therapy Tape Notes: class 2
Desc: Precut Kinesiology Tape (Calf & Achilles Support; Foot Support)
Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits
are not subject to DWPE
Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits
are not subject to DWPE
Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits
are not subject to DWPE
Desc: Renegade Bolero Pump
Desc: Renegade Bolero Pump
Desc: Ultrasonic Scaler (B5 Model) Notes: Class II
Desc: Face Mask Notes: Device Classification is unknown
Desc: Auvon TENS Massager - Model AS
Desc: Nursal TENS and Powered Muscle Stimulator Model AS Notes: DWPE Date 06/15/
Desc: Auvon TENS and Powered Muscle Stimulator Model TA Notes: Class II
There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.
Desc: Auvon TENS Massager - Model AS Notes: Class II;
There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.
Desc: Auvon TENS Massager - Model AS
Desc: Auvon TENS and Powered Muscle Stimulator Model TA Notes: Class II
There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.
Desc: Auvon TENS Massager - Model AS Notes: Class II;
There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market.
Desc: Auvon TENS Massager - Model AS
Desc: Nursal TENS and Powered Muscle Stimulator Model AS Notes: DWPE Date 06/15/
Desc: EKSV-10A Urinalysis Test Strips Notes: class II
Desc: EKSV-10A Urinalysis Test Strips Notes: class II
Desc: EKSV-10A Urinalysis Test Strips Notes: Class II
Desc: EKSV-10A Urinalysis Test Strips Notes: class II
Desc: EKSV-10A Urinalysis Test Strips Notes: class II
Desc: EKSV-10A Urinalysis Test Strips Notes: class II
Desc: EKSV-10A Urinalysis Test Strips Notes: Class II
Desc: EKSV-10A Urinalysis Test Strips Notes: class II
Desc: EKSV-10A Urinalysis Test Strips Notes: Class II
Desc: EKSV-10A Urinalysis Test Strips Notes: Class II
Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator Notes: DWPE Date 7/20/
Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator Notes: DWPE Date 7/20/
Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator Notes: DWPE Date 7/20/
Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator Notes: DWPE Date 7/20/
Desc: Ultrasound Scanner Notes: DWPE Date 11/8/
Desc: Ultrasound Scanner Notes: DWPE Date 11/8/
Desc: Ultrasound Scanner Notes: DWPE Date 11/8/
Desc: Multifunction Infrared Thermometer Notes: Class II Device. The Agency is unable to determine if the product is a device subject to a previously cleared 510(K) due to the lack of information in the product materials.
Desc: BU-908 Electronic Convex Ultrasound Scanner Notes: DWPE Date 12/8/
Desc: BU-908 Electronic Convex Ultrasound Scanner Notes: DWPE Date 12/8/
Desc: BU-908 Electronic Convex Ultrasound Scanner Notes: DWPE Date 12/8/
Desc: IDream3 Eye and Head Massager
Desc: ISee108 Eye Massager
Desc: IDream3 Eye and Head Massager
Desc: iSee4 massager
Desc: uCrown Pro Head Notes: class II
Desc: iComfort Eye-Z Eye and Temple Massager Notes: class II
Desc: iSee4 massager
Desc: iDream 3 Head Massagers Notes: 12/23/
Desc: iDream 5S Head Massagers Notes: 12/23/
Desc: iComfort Eye-Z Eye and Temple Massager Notes: class II
Desc: uCrown Pro Head & Eye Massager Notes: class II
Desc: IDream3 Eye and Head Massager
Desc: iDream 5S Head Massagers Notes: 12/23/
Desc: iSee4 massager
Desc: ISee108 Eye Massager
Desc: IDream3 Eye and Head Massager
Desc: uCrown Pro Head Notes: Class II
Desc: iComfort Eye-Z Eye and Temple Massager Notes: Class II
Desc: iDream 3 Head Massagers Notes: 12/23/
Desc: SARS-CoV-2 Antigen Rapid Detection Kit
Desc: SARS-CoV-2 Antigen Rapid Detection Kit
Desc: Stimulator; Nerve; Transcutaneous; For Pain Relief Notes: Class II
Desc: Stimulator; Nerve; Transcutaneous; For Pain Relief Notes: Class II
Desc: Digital Therapy Machine Tens Unit Notes: class II
Desc: Derma Rollers
Desc: Stay Hard Beaded Cockrings
Desc: Penis Enlarger and Penis Extender Notes: Class II
Desc: Penis Enlarger and Penis Extender Notes: class II
Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1
Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2
Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2
Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1
Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1
Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2
Desc: Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado) Notes: class II
Desc: Iriscope (Iriscopio) Notes: Class II
Desc: Digital Blood Pressure Monitor Models; B01; B02; B05 & B06T
Desc: Micro Needle Roller Notes: Class II
Desc: Micro Needle Roller Notes: Class II
Desc: COVID-19 DART
Desc: Foot detox machine Notes: class II
Desc: Foot detox machine Notes: class II
Desc: Breast Enhancer Massager Notes: class II
Desc: Breast Enhancer Massager Notes: class II
Desc: Breast Enhancer Massager Notes: class II
Desc: Breast Enhancer Massager Notes: class II
Desc: Breast Enhancer Massager Notes: Class II
Desc: Breast Enhancer Massager Notes: class II
Desc: Synergy Face Massager
Desc: Synergy Eye Massager
Desc: Synergy Eye Massager
Desc: Synergy Face Massager
Desc: Synergy Eye Massager
Desc: Synergy Eye Massager
Desc: Synergy Face Massager
Desc: COVID-19 Real-Time Fluorescence PCR Detection Kit (lyophilized)
Desc: Snore Stopper
Desc: Detox Ion Foot Cleanse Notes: CLASS II
Desc: Detox Ion Foot Cleanse Notes: CLASS II
Desc: Blackhead Remover
Desc: Blackhead Remover
Desc: Blackhead Remover
Desc: Transcutaneous Nerve Stimulator Notes: Class II
Desc: Transcutaneous Nerve Stimulator Notes: Class II
Desc: Transcutaneous Nerve Stimulator Notes: Class II
Desc: Transcutaneous Nerve Stimulator Notes: Class II
Desc: Transcutaneous Nerve Stimulator Notes: Class II
Desc: Transcutaneous Nerve Stimulator Notes: Class II
Desc: Transcutaneous Nerve Stimulator Notes: Class II
Desc: Eye Massager Notes: Class II
Desc: Eye Massager Notes: Class II
Desc: COVID-19 IgG/IgM Detection Kit (Colloidal Gold)
Desc: Singuway COVID-19 Test Kit
Desc: Intense Pulsed Light (IPL) System (Non-Laser) Notes: Class II
Desc: Intense Pulsed Light (IPL) System (Non-Laser) Notes: Class II
Desc: Carpal Support Gloves
Desc: Capillus 272 Laser Hair Cap Notes: Class III
Desc: Capillus 272 Laser Hair Cap Notes: Class III
Desc: Diode Laser Beauty Machine
Desc: Anti Snore Chin Strap Notes: Products do not have a valid 510(K) clearance.
Desc: Anti Snore Chin Strap Notes: Products do not have a valid 510(K) clearance.
Desc: Penis Ring Notes: Class II; 12/10/12
Desc: Rebound Tonometer
Desc: Nerve and Muscle Stimulator
Desc: Nerve and Muscle Stimulator
Desc: Nerve and Muscle Stimulator
Desc: FastPlex Triplex SARS-CoV-2 Detection Kit (RT- PCR)
Desc: Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs
Desc: Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs
Desc: Detox Foot Pads (Luminositie)
Desc: Ultrasound Gel
Desc: Ultrasound Gel
Notes: 2/16/ HIV Self Test Kit HIV Diagnostic Kits are Class III
devices within the meaning of Section 513(f)(1) of the Act and are
regulated by CBER under the current intercenter agreement between
CDRH and CBER. The unapproved diagnostic test kits claim to detect
HIV antibodies in blood or saliva and provide results in the home in
15 minutes or less. The test kits are imported into the US through
the mail and may be entered as Asamples@ or for Apersonal usa@. The
contents may be labeled Afor investigational use@ for Aresearch use@
or Afor export only @. The test kits could present a serious hazard
to the public health; including possible HIV transmission to
partners and delayed access to medical care due to mis-diagnosed
false negative tests. If entries are encounted; contact CBER
Import/Export team at 301-827-.
Notes: 2/16/ HIV Self Test Kit HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: Detox Foot Pads (Luminositie)
Desc: QuikPac II Covid-19 IgG & IgM Test
Desc: Transcutaneous Electrical Nerve Stimulator (Portable High Frequency) Notes: Class II
Desc: Transcutaneous Electrical Nerve Stimulator (Portable High Frequency) Notes: Class II
Desc: Pinhole Sunglasses Notes: Class II
Desc: Pinhole Glasses Notes: Class II
Desc: Pinhole Sunglasses Notes: Class II
Desc: Pinhole Glasses Notes: Class II
Desc: Reusable Adult Ear Clip Sensors (U903-01) Oximeter
Desc: Disposable SpO2 Sensors (Oximeters); Nellcor Oximax Compatible
Desc: Reusable Adult Finger Clip Sensor (U403-49 or U403-49R) Oximeter
Desc: Reusable SpO2 Sensor/Masimo/finger clip/Adult/1 1M/125; U403-125R
Desc: Disposable MAS-LINCS Pdtx SpO2 Sensors
Desc: Reusable Adult Ear Clip Sensors (U903-01) Oximeter
Desc: Reusable SpO2 Sensor/CSI/finger clip/Adult/3 0M/DB9 U410-75
Desc: Reusable SpO2 Sensors (Oximeters)
Desc: Reusable Adult Finger Clip Sensor (U403-49 or U403-49R) Oximeter
Desc: Reusable Adult Ear Clip Sensors (U903-01) Oximeter
Desc: EasyNAT Diagnostic Kit for Novel- Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay
Desc: ESPADA 2 plus (ACNE CLEARING BLUE LIGHT PEN)
Desc: VivaDiag COVID-19 IgM/IgG Rapid Test
Desc: VivaDiag COVID-10 IgM/IgG Rapid Test
Desc: VivaDiag COVID-19 IgM/IgG Rapid Test
Desc: Intense Pulsed Light System Face Skin Cleaner Notes: Class II
Desc: Ultrasonic Cavitation Devices Notes: class II
Desc: Ultrasonic Cavitation Devices Notes: class II
Desc: Ultrasound Beauty Machine Notes: Class II; 11/02/
Desc: Massager Notes: Class II; 3/8/
Desc: Massager Notes: Class II
Desc: Ultrasonic Cavitation Devices Notes: Class II
Desc: Massager Notes: class II
Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test
Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test
Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test
Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test
Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test
Desc: Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test
Desc: Medical Laser Notes: Class II
Desc: Medical Laser Notes: Class II
Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles Notes: Class II
Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles Notes: class II
Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles Notes: class II
Desc: Massage Machine
Desc: Smart Cuff
Desc: Massagers Models; OS-102A; 103A; 105A; 106A; & 107A ONLY Notes: Class II
Desc: Dermaroller Notes: class II
Desc: EVANLAS Therapy Laser System
Desc: EVANLAS Therapy Laser System
Desc: EVANLAS Therapy Laser System
Desc: EVANLAS Therapy Laser System
Desc: EVANLAS Therapy Laser System
Desc: EVANLAS Therapy Laser System
Desc: EVANLAS Therapy Laser System
Desc: EVANLAS Therapy Laser System
Desc: SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography)
Desc: Szybio Life Origin Biotech SARS-SoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography)
Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application
Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application
Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application
Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application
Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application
Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold)
Desc: COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)
Desc: COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)
Desc: COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)
Desc: COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)
Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)
Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)
Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)
Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)
Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)
Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)
Desc: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device
Desc: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device
Desc: SARS-CoV-2 Antigen Rapid Test
Desc: COVID-19 Risk Test
Desc: Leg Massager with Heat Notes: Only the following models are subject to the alert: EMK-702, EMK-707, EMK-703B, EMK-707B, SHI-66, SHI-77, RF-ALM072-H, EMK-712, RP-ALM075
Desc: Leg Massager with Heat Notes: Only the following models are subject to the alert: EMK-702, EMK-707, EMK-703B, EMK-707B, SHI-66, SHI-77, RF-ALM072-H, EMK-712, RP-ALM075
Desc: LEG MASSAGER; model RF-ALM071
Desc: LEG MASSAGER; model RF-ALM071
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: Sxkeysun Cryolipolysis Slimming Machine
Desc: SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST
Desc: INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test
Desc: Innova COVID-19 Self-Test kit
Desc: SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST
Desc: BIOTIME SARS-CoV-2 Antigen Rapid Qualitative Test
Desc: Multifunctional Massager Notes: Class III
Desc: Electric massagers Mio and Ami and Je Joue Brandd Vibrators Notes: Class II
Desc: Electric massagers Mio and Ami and Je Joue Brandd Vibrators Notes: class II
Desc: Electric massagers Mio and Ami and Je Joue Brandd Vibrators Notes: class II
Desc: DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2
Desc: DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2
Desc: DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2
Desc: DIAGNOSTIC KIT (COLLOIDAL GOLD) FOR IGG/IGM ANTIBODY TO SARS-COV-2
Desc: Rebound Tonometer
Desc: Body Massager Notes: Class I device; requires 510(k)
Desc: Cupping Therapy Set
Desc: Cupping Therapy Set
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Desc: Electrical Facial Mask
Desc: Electrical Facial Mask
Desc: Handheld Foot Massager Notes: Class 2;For example; claims include Rehabilitation treatment for the diseases such as headaches; migraine headaches; neck and shoulder acid; stomach pain; fatigue; abnormal blood pressure; constipation; weight loss; detoxification; lack of sleep; insomnia; cold; pressure; dysmennorheal; menopause syndrome; irregular menstruation; infertility; etc.
Desc: Handheld Foot Massager Notes: Class 2;For example; claims include Rehabilitation treatment for the
diseases such as headaches; migraine headaches; neck and shoulder acid;
stomach pain; fatigue; abnormal blood pressure; constipation; weight loss;
detoxification; lack of sleep; insomnia; cold; pressure; dysmennorheal;
menopause syndrome; irregular menstruation; infertility; etc.
Desc: Novel Coronavirus (nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography)
Desc: Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography)
Desc: Sterile Surgical Mask
Desc: KN95 Face Mask
Desc: Medical Face Mask
Desc: Medical Face Mask
Desc: Sterile Surgical Mask
Desc: KN95 Face Mask
Desc: KN95 Face Mask
Desc: COVID-19 IgM Antibody Rapid Test Kit
Desc: COVID-19 IgG Antibody Rapid Test Kit
Desc: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)
Desc: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)
Desc: COVID-19 IgM Antibody Rapid Test Kit
Desc: COVID-19 IgG Antibody Rapid Test Kit
Desc: COVID-19 IgM Antibody Rapid Test Kit
Desc: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)
Desc: COVID-19 IgG Antibody Rapid Test Kit
Desc: SL-50 Cluster Laser Notes: Class II
Desc: SL-50 Cluster Laser Notes: Class II
Desc: Electric Acupuncture Pen Notes: Class II
Desc: SL-50 Cluster Laser Notes: Class II
Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test
Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test
Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test
Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test
Desc: COVID-19 Antigen Detection Kit (Collodial Gold)
Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)
Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)
Desc: COVID-19 Diagnostic Kit for IgM/IgG Antibody to Corona Virus (nCoV-)(Colloidal Gold)
Desc: Livzon Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)
Desc: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)
Desc: Nitrile Patient Examination Gloves
Desc: Black Lightning Powder Free Nitrile Examination Gloves pH 5.5 (sizes M L XL XXL) Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.
Desc: Megaman Powder-Free Black Nitrile Flock-Lined Examination Gloves (size XXL) Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation. Only size XXL is subject to the alert.
Desc: BODY BACK STICKS - PLASTIC MANUAL MASSAGERS Notes: The device has no 510(k) clearance
Desc: Portable Smart Massage U Disc Tens Unit Notes: Class II; 6/2/
Desc: COVID-19 Antigen
Desc: COVID-19 Antigen
Desc: COVID-19 Antigen
Desc: C-19 Quik Test
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) Notes: Class III
Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) Notes: Class III
Desc: OXYGEN FACIAL PURIFIER Notes: Problem(s);
Lacks 510(k)
Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) Notes: Class III
Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) Notes: Class III
Desc: REG 3 Pro Touch
Desc: Vega Light Therapy Device
Desc: Jupiter Light Therapy Device
Desc: Jupiter Light Therapy Device
Desc: Neptune Light Therapy Device
Desc: Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device
Desc: Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device
Desc: Boston Bio EZ COVID-19
Desc: SARS-CoV-2 IgG/IgM Rapid Test
Desc: Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device
Desc: Chisoft Neck Stretcher
Desc: Dr. Fargo Photon Energy Detoxification Bag Notes: Class II Device (may be a Class III). The device claims made are varied and the mechanism of technology of the device is and it is unclear how the device produces the intended effects are unclear. CDRH is not aware of any predicate devices that the manufacturer may compare to for 510(k) submission. Therefore; there is no specific product code or regulation that applies to this device since there are no known predicate device(s).
Desc: PF VINYL PATIENT EXAM GLOVES; NON-STERILE; NON COLORED
Desc: Body Shaper Notes: "Lipo Illusion" Compression Garment; Class II
Desc: Skin Dermo Therapies Kit Notes: Class I
Desc: Stimulator Electro-Acupuncture Notes: Class III
Desc: Medical Support Stockings Notes: Class II
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: RespiPro Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: RespiPro Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: RespiPro Respirator
Desc: RespiPro Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: Self Sterilizing FFP2 Nano Respirator
Desc: RespiPro Respirator
Desc: Would Be Gone Wound Healing Gel Notes: Class I
Desc: Would Be Gone Wound Healing Gel Notes: Class I
Desc: Would Be Gone Wound Healing Gel Notes: Class I
Desc: Auri Kit; Clamp ear pinning kit Notes: class II
Desc: Auri Kit; Clamp ear pinning kit Notes: Class II
Desc: Penile Extender Notes: Class II
Desc: Penile Extender Notes: Class II
Desc: Penile Extender
Notes: Jes-Extender (penis extending device)12/18/
Notes: Jes-Extender (penis Extending Device 12/18/
Desc: Auri Kit; clamp ear pinning kit Notes: class II
Desc: Auri Kit; clamp ear pinning kit Notes: Class II
Desc: Saltarium Salt Cocoon Notes: Class II
Desc: NUROSYM
Desc: NUROSYM
Desc: NUROSYM
Desc: NUROSYM
Desc: NUROSYM
Desc: Sybaritic Inc. (Sybaritic) Hydration Station Notes: Class II; 9/1/
Desc: ArcDia mariPOC SARS CoV2
Desc: mariPOC SARS-CoV-2 by ArcDia international Oy Ltd
Notes: Tetanus IgG EIA Kit
Desc: GSP/DELFIA Anti-SARS-CoV-2 IgG Kit
Desc: UltraGene Combo2Screen SARS-CoV-2 assay
Desc: COVID19 Speed Test Strip
Desc: COVID19SEROSpeed-lgM-lgG Rapid IgG/IgM Test
Desc: Biosynex COVID19 BSS
Desc: Sterile Surgical Gloves
Desc: DualChroma/Chromapuncteur-10 Notes: Class II
Desc: DualChroma/Chromapuncteur-10 Notes: Class II
Notes: Oxane; Purified Silicone Oil (Intraocular Fluid for Retinal Re-attachment) 5/31/
Desc: EasyCOV
Desc: Skeen Patch
Desc: Skeen Patch
Desc: Skeen Patch
Desc: Skeen Patch
Desc: Urine Test Strip
Notes: All devices. GPI = DE.
Notes: All devices. GPI = DE. 12/28/
Notes: LARS (Ligament Advanced Reinforcement System) 10/13/
Notes: Ligastic Artificial Ligaments. 10/13/
Notes: 8/26/ Outline Ultra A Bioresorbable Polycrylamide Filler for Soft Tissue.
Notes: Audiokinetron Device. 3/29/.
Notes: 9/9/ Chorus RM cardia pacemaker model . Chorus II cardia pacemaker model
Notes: Presso Dan 207 Pressure therapy apparatus 8/02/01
Notes: Electronic Ear; or any device labeled or marked for auditory training; auditory integration or behavioral improvement.
Notes: Electronic Ear or any deviced labled or marked for auditory training; auditory integration; or behavioral improvement. 2/5/
Desc: COVID-19-CHECK-1
Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k
Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k
Desc: Intraarticular hyaluronic acid; EUFLEXXA
Desc: AESKULISA? SARS-CoV-2 NP IgM
Desc: AESKULISA SARS-CoV-2 S1 IgG
Desc: AESKULISA SARS-CoV-2 S1 IgM
Desc: AESKULISA SARS-CoV-2 NP IgG
Notes: Ondamed System Regulation Biofeedback Device 4/29/
Notes: Ondamned System Regulation (Biofeedback Device) 4/29/ Lack of 510(k) Approval.
Desc: Vivalytic VRI
Desc: Vivalytic Viral Respiratory tract Infections
Desc: Brain Amps Notes: Class II
Desc: DPP SARS CoV-2 IgM/IgG with DPP Micro Reader II
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Notes: All Devices;class I/II/III
Desc: Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA and Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA Research Use Only (RUO)
Desc: Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA and Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA Research Use Only (RUO)
Desc: Pocket Darkroom Contact Lenses Notes: Class II
Desc: Pocket Darkroom Contact Lenses Notes: Class II
Desc: Pocket Darkroom Contact Lenses Notes: Class II
Desc: Pocket Darkroom Contact Lenses Notes: Class II
Desc: Pocket Darkroom Contact Lenses Notes: Class II
Desc: Pocket Darkroom Contact Lenses Notes: Class II
Desc: Pocket Darkroom Contact Lenses Notes: Class II
Desc: Pocket Darkroom Contact Lenses Notes: Class II
Desc: Pocket Darkroom Contact Lenses Notes: Class II
Desc: Quantron Resonance System (Body Stimulator) Notes: class II
Desc: SARS-CoV-2 IgG ELISA Test Kit
Desc: Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
Desc: VirellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0
Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k
Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k
Desc: SERION ELISA agile SARS-CoV-2 IgG
Desc: SERION ELISA agile SARS COV-2 IgA
Desc: Thoracic Trocar Notes: Class 2
Desc: Valvulatome Notes: Class 2
Desc: Traction Tongs Notes: Class 2
Desc: Hudson Burr 14mm; (Item# VM NL2SO) Notes: Class 2
Desc: Clamping Device with Ball and Socket (Item# VM NLISO) Notes: Class 2
Desc: Adson Perforating Bur; 14mm (Item# VM NL190)
Desc: McKenzie Perforating Twist Drill; 13mm (Item# VMNL200) Notes: Class 2 ;
Desc: McKenzie Enlarging Burr; 16mm (Item# VM NL270) Notes: Class 2
Desc: Hudson Burr; 12mm; 8 teeth; tapered (Item# VM NL180) Notes: Class 2 ;
Desc: Uterine Tenaculum Hook Notes: Class 2
Desc: Uterine Tenaculum Forceps Notes: Class 2
Desc: Endometrium Notes: Class 2
Desc: Circumcision Clamps Notes: Class 2
Notes: Spinal Anethesia Tray; COSPAN Continuous Spinal Anesthesia Tray; COSPAN Pediatric Spinal Anesthesia Tray; Curity Pediatric Continuous Spinal Anesthesia Tray.
Desc: MEDSAN COVID-19 IgM/IgG RAPID TEST
Desc: MEDSAN COVID-19 IgM/IgG RAPID TEST
Desc: MEDSAN COVID-19 IgM/IgG RAPID TEST
Desc: EROS Brand Cosmetic Gels personal lubricants Notes: Class II
Desc: CCL Vario Demo For Trade Show
Desc: CCL Vario Demo Unit
Desc: CCL 365 Corneal Cross-Linking System
Desc: CCL 365 Vario Ultraviolet Lamp;
Desc: Phoenix Demo for Trade Show
Desc: UV-Lamp for Animal Use
Desc: UV Lamp
Desc: Phoenix Demo for Trade Show
Desc: CCL Vario Demo Unit
Desc: CCL 365 Vario Ultraviolet Lamp
Desc: CCL 365 Corneal Cross-Linking System
Desc: CCL Vario Demo For Trade Show
Desc: CCL 365 Corneal Cross-Linking System
Desc: CCL 365 Vario Ultraviolet Lamp
Desc: Phoenix Demo for Trade Show
Desc: CCL Vario Demo Unit
Desc: CCL Vario Demo For Trade Show
Desc: UV-Lamp for Animal Use
Desc: UV Lamp
Desc: Microneedling device Notes: Class II
Desc: Microneedling device Notes: Class II
Desc: Microneedling device Notes: Class II
Desc: Microneedling device Notes: Class II
Desc: NADAL COVID-19 IgG/IgM Test
Desc: NADAL COVID-19 IgG/IgM Test
Notes: DE = Nostrafon SK2 Sound Wave Appliance. Medi-Pol (magnetic field therapy used
as an accessory device with Nostrafon Unit).
Notes: 3/5/ miniZAP Blood Zapper
Notes: Ondamed System Regulation Biofeedback Device 4/29/
Desc: Breast Pump Notes: Class II
Desc: TiLENE Plug Set (surgical mesh) Notes: Class II device without 510k
Desc: TiLENE Guard Set (surgical mesh) Notes: Class II device without 510k
Desc: TiLENE Strip (surgical mesh) Notes: Class II device without 510k
Desc: TiLENE Guard (surgical mesh) Notes: Class II device without 510k
Desc: TiSURE (surgical mesh) Notes: Class II device without 510k
Desc: TiLENE Plug (surgical mesh) Notes: Class II device without 510k
Desc: TiLENE Plug Set (surgical mesh) Notes: Class II device without 510k
Desc: TiLENE Guard Set (surgical mesh) Notes: Class II device without 510k
Desc: TiLENE Guard (surgical mesh) Notes: Class II device without 510k
Desc: TiLENE Plug (surgical mesh) Notes: Class II device without 510k
Desc: TiSURE (surgical mesh) Notes: Class II device without 510k
Desc: TiLENE Strip (surgical mesh) Notes: Class II device without 510k
Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test
Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test
Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test
Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test
Desc: Perometer
Desc: Perometer
Notes: All devices. Manufacturers for Anti-Aging Solutions. Revitalite Beautfying
Soft Light Laser.
Desc: Flexpulse
Desc: Flexpulse
Desc: Flexpulse
Desc: Fibroplast Pen 3.5 Thunder w/ Needles
Desc: Fibroplast Pen 3.5 Thunder w/ Needles
Desc: Fibroplast Pen 3.5 Thunder w/ Needles
Desc: Fibroplast Pen 3.5 Thunder w/ Needles
Desc: ENTV-Dx LFR reader
Desc: RAYOCOMP PS 10
Desc: Fabric Detector
Desc: RAYOCOMP PS 10
Desc: Infrared/Laser 70MW/785NM Laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.
Desc: Infrared/Laser 70MW/785NM Laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.
Desc: Infrared/Laser 70MW/785NM laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.
Desc: Infrared/Laser 70MW/785NM laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.
Desc: Infrared/Laser 70MW/785NM Laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.
Desc: Infrared/Laser 70MW/785NM Laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.
Desc: Infrared/Laser 70MW/785NM laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.
Desc: Infrared/Laser 70MW/785NM laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.
Notes: Magnetic Devices No classification name, number or regulation citation.
2/29/
Desc: SARS-CoV-2 Quick
Desc: SARS-CoV-2 Quick
Desc: Bloom COVID-19 Test
Notes: Silicone Oil for Opthalmic Use (Sterile)
Desc: Epi-No Delphine Trainer Plus Notes: 9/13/
Desc: Synvisc Hylan Syringe Kits Notes: (Product has European label which contains indications for use not yet approved in the United States); Class III; 6/20/
Desc: Facial Treatment Device (ECOderm) Notes: Class II device.
Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application
Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application
Desc: Facial Treatment Device (ECOderm) Notes: Class II device.
Desc: Facial Treatment Device (ECOderm) Notes: Class II device.
Desc: Facial Treatment Device (ECOderm) Notes: Class II device.
Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application
Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application
Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application
Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application
Desc: Terror Eyes Fashion Lenses Notes: Class II
Desc: Terror Eyes Fashion Lenses Notes: Class II
Desc: Terror Eyes Fashion Lenses Notes: Class II
Desc: Terror Eyes Fashion Lenses Notes: Class II
Desc: Terror Eyes Fashion Lenses Notes: Class II
Desc: Terror Eyes Fashion Lenses Notes: Class II
Desc: Terror Eyes Fashion Lenses Notes: Class II
Desc: Terror Eyes Fashion Lenses Notes: Class II
Desc: Terror Eyes Fashion Lenses Notes: Class II
Desc: Fashion Contact Lenses "Terror Eyes" Notes: Class II; 9/25/
Desc: PAP-IMI Ion Magnetic Conductor Device Notes: Unclassified
Desc: Portable High Frequency Spot Remover; JX-006A Massager Notes: Class II/III
Desc: Portable High Frequency Spot Remover; JX-006A Massager Notes: Class II/III
Desc: Portable High Frequency Spot Remover; JX-006A Massager Notes: Class II/III
Desc: GS8.0 Cavitation Machine Notes: class II
Desc: GRF-11 Monopolor Radio Frequency Machine Notes: class II
Desc: GS8.0 Cavitation Machine Notes: Class II
Desc: GRF-11 Monopolor Radio Frequency Machine Notes: Class II
Desc: SYL-06 (1MHz) Physiotherapy Ultrasound SYL-07 (3 MHz) Physiotherapy Ultrasound Notes: Class II
Desc: Soozier 2in1 Personal Facial & Hair Steamer Notes: Unknown Device Classification. Product labeling appear to indicate the device both
treats and prevents diseases or conditions including dandruff; "treat the scalp",
and skin pigmentation disorders. It also indicates to affect the structure and
function of the body of man. Specifically the sponsor describes the device to
speed nutrient absorption; sterilize and whiten skin; improve blood circulation and
metabolism.
Desc: Bio Hydroderm Hydrodermabrasion System Notes: Class II
Desc: Bio-Synthesis Light activated facial rejuvenation system Notes: Class II
Desc: Bio-Hydroderm V2 Microderm Abrasion units Notes: Class II
Desc: Bio Hydroderm Hydrodermabrasion System Notes: Class II
Desc: Bio-Synthesis Light activated facial rejuvenation system Notes: Class II
Desc: Bt-Micro Dermabrasion Unit Notes: class II
Desc: Bt-Micro Dermabrasion Unit Notes: class II
Notes: The Shealy RelaxMate (aka RelaxEase) 8/27/
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: Class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Notes: All devices. GPI = DE. Shealy Relaxmate Glasses. 5/6/.
Notes: WhisperXL mini-sound amplifier (behind the ear hearing aid) 12/21/
Desc: Smart Swab
Desc: Smart Swab
Desc: Finger Rollers Notes: Class I
Desc: Hothouse FIR Health Builder Notes: Reason; Lacks 510(k); 11/26/
Desc: Contact Lenses (circle lenses) Notes: Class II
Desc: Contact Lenses (circle lenses) Notes: Class II
Desc: Contact Lenses (circle lenses) Notes: Class II
Desc: Contact Lenses (circle lenses) Notes: Class II
Desc: Contact Lenses (circle lenses) Notes: Class II
Desc: Contact Lenses (circle lenses) Notes: Class II
Desc: Contact Lenses (circle lenses) Notes: Class II
Desc: Contact Lenses (circle lenses) Notes: Class II
Desc: Contact Lenses (circle lenses) Notes: Class II
Desc: Portable High Frequency LZ-006A
Desc: Saliva Glucose Tracker
Desc: Saliva Glucose Tracker
Desc: Saliva Glucose Tracker
Desc: Saliva Glucose Tracker
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/
Desc: Genelogic COVID-19 IgM/IgG Antibody Rapid Test
Desc: SARS-CoV-2 IgM/IgG Antibody Lateral Flow Assay
Desc: Silicon Cupping Sets
Desc: Silicon Cupping Sets
Desc: -nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)
Desc: -nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)
Desc: -nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)
Desc: -nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Notes: All Devices products; Class I, II, III
Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)
Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)
Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)
Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/
Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/
Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/
Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/
Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/
Desc: OMAR Powder-Free Nitrile Examination Gloves White
Desc: OMAR Powder-Free Nitrile Examination Gloves White
Desc: PF VINYL PATIENT EXAM GLOVES; NON-STERILE; NON COLORED
Desc: Ion Cleanse Massager Notes: class II
Desc: Ion Cleanse Massager Notes: Class II
Desc: NARL 517 MS (Beauty Equipment Massager) Notes: Class III
Desc: NARL 517 MS (Beauty Equipment Massager) Notes: Class III
Desc: Circle HealthPod Rapid Detention System for Covid 19
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Desc: Breast Massager
Desc: Breast Massager
Desc: Breast Massager
Desc: API Covid-Rapid IgM/IgG Antibody Test Kit
Desc: API Covid-Rapid IgM/IgG Antibody Test Kit
Desc: API Covid-Rapid IgM/IgG Antibody Test Kit
Notes: Emjoi Body Fat Monitor AP-30 (Body Composition Analyzer) 8/26/. Lack of 510(k) Approval.
Notes: OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Notes: OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/. HIV
Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1)
of the Act and are regulated by CBER under the current intercenter agreement
between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV
antibodies in blood or saliva and provide results in the home in 15 minutes or
less. The test kits are imported into the US through the mail and may be
entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor
investigational use@ for Aresearch use@ or Afor export only @. The test kits
could present a serious hazard to the public health; including possible HIV
transmission to partners and delayed access to medical care due to mis-
diagnosed false negative tests. If entries are encounted; contact CBER
Import/Export team at 301-827-.
Desc: Shaker Teether Toy Notes: Class II; 10/5/
Desc: Gel Filled Infant Teether Notes: Class II; 10/5/
Desc: Day Light Bright Light Therapy Systems Notes: Class II
Desc: Muscle Stimulator Notes: Class II
Desc: Muscle Stimulator Notes: CLASS -- II
Desc: Micro Needle Skin Roller Notes: class II
Desc: SL-50 Cluster Laser Notes: Class II
Desc: SL-50 Cluster Laser Notes: Class II
Desc: SL-50 Cluster Laser Notes: Class II
Notes: Pollogen Regan/Pollegen MJ 5/12/ Shipper for Pollegen Ltd.
Notes: Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/.
Desc: The Quantum Xrroid Consciousness/Medical Interface System Unclassified Notes: 6/28/
Desc: Educator Biofeedback Device
Desc: GenePath CoViSwift v3.0
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Desc: Agent Aborbable Hemostatic Collagen Blend Notes: Class III
Desc: Intraocular Lens Guides; Intraocular Lenses Notes: Class III
Desc: Intraocular Lens Guides; Intraocular Lenses Notes: Class III
Desc: Intraocular Lens Guides; Intraocular Lenses Notes: Class III
Notes: Intraocular Lens
Desc: Intraocular Lens Guides; Intraocular Lenses Notes: Class III
Notes: Appavisv PFS Hydroxypropyl Methyl Cellulose Opthalmic Solution USP 2% Labeled for Intracular Use 6/19/
Desc: COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit
Desc: BGX COVID-19 RT-PCR
Desc: COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit
Desc: Condom
Desc: Condom
Desc: Sterilizer Glass Bead
Desc: Sterilizer Glass Bead
Desc: Sterilizer Glass Bead
Desc: GenePath CoViSwift v3.0
Notes: Latex Condoms 7/6/
Desc: Latex Condoms Notes: 5/16/
Notes: Latex Condoms 7/6/
Notes: Latex Condoms 7/6/
Notes: All devices GPI = DE. Freeman Universal Intraocular Lenses (IOL) Anterior
Chamber Optional Posterior Chamber. Style Code IMD-AC-FA. 7/6/.
Desc: ACCUCARE COVID-19 IgG/IgM Lateral Flow Assay Test Kit
Notes: Condoms 3/15/
Notes: Condoms 3/15/
Notes: Condoms 3/15/
Desc: Truenat%u SARS CoV-2
Desc: Truenat%u Beta CoV
Desc: PathoCatch COVID-19 Antigen Lateral Flow Test Device
Notes: Condoms 3/10/
Notes: Condoms 3/10/
Notes: Condoms 3/10/
Desc: Medical Syringes Notes: class II
Desc: Medical Syringes Notes: class II
Desc: Medical Syringes Notes: class II
Notes: Intraocular Lenses 4/10/.
Desc: Collagen handpiece
Desc: Collagen handpiece
Desc: UltraB handpiece
Desc: AquaB handpiece
Desc: MicroT handpiece
Desc: UltraB handpiece
Desc: Preime Dermafacial Device
Desc: MicroT handpiece
Desc: Splint; Intranasal Septal Notes: Class I; Synaero
Desc: ECG/EMG Integretion Shimmer
Desc: ECG/EMG Integretion Shimmer
Desc: Occlusion Cuff Pneumatic Tourniquet
Desc: Occlusion Cuff Pneumatic Tourniquet
Desc: Airway Medix Closed Suction Systems Notes: Class II
Desc: Tripollar POSE; Tripollar STOP Notes: Class II
Desc: Invasix BodyTite (aka Invasix RFAL Notes: Class II
Desc: Radialspec Notes: Class III
Desc: Pollogen Apollo Notes: Class III; 5/12/
Notes: Pollogen Regan; 5/12/; Class III
Desc: Tripollar POSE; Tripollar STOP Notes: Class II
Notes: HIV I and II One Step Tests 7/9/. Several FDA districts have encountered shipments of unapproved test kits and labeled for "research use only" or "investigationa use only" and some of the kits were unlabeled. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. Investigation by FDA revealed that the unapprived HIV diagnostic test kits were intended for commercial distribution; and not for "research" or "investigation" uses as invoiced. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-
Desc: HIV-I II One-Step Test and Quick AIDS Test Notes: 8/23/
Desc: HIV-I II One-Step Test and Quick AIDS Test Notes: 8/23/
Desc: SkinBella Crystal-Free Microdermabrasion System Notes: Class I; Firm has no 510K for the product
Notes: SkinMaster MicroDermabrasion Product 1/2/
Notes: SkinMaster MicroDermabrasion Product 1/2/
Notes: In vitro diagnostic products
Notes: In vitro diagnostic products
Notes: In vitro diagnostic products
Notes: In vitro diagnostic products
Notes: In vitro diagnostic products
Notes: In vitro diagnostic products
Notes: In vitro diagnostic products
Desc: Physia Pain Relief Machine Notes: class II
Desc: Di Blasi R30; 3-wheeled Scooter
Desc: Di Blasi R30; 3-wheeled Scooter
Desc: HC Cryo T-Shock
Desc: Cryoskin
Desc: Endospheres Device
Desc: Endospheres Device
Desc: Endospheres Device
Desc: Endospheres Device
Desc: FRAS 5 (Free Radical Analytical System) Device & Sample Kit
Desc: FRAS 5 (Free Radical Analytical System) Device & Sample Kit
Desc: bKIT Virus Finder COVID-19
Desc: Long-Lasting Personal Lubricant
Desc: Long-Lasting Personal Lubricant
Desc: Long-Lasting Personal Lubricant
Notes: 12/08/ Pacemaker (Phymos ADV/VDD-M)
Desc: Perfluorodecaline Notes: Class III; 8/18/
Desc: GasMate Notes: Class III; 8/18/
Desc: Intraocular Silicone Oil Notes: Class III; 8/18/
Desc: Perfluorodecaline Notes: Class III; 8/18/
Desc: Intraocular Silicone Oil Notes: Class III; 8/18/
Desc: GasMate Notes: Class III; 8/18/
Desc: Intraocular Silicone Oil Notes: Class III; 8/18/
Desc: GasMate Notes: Class III; 8/18/
Desc: Perfluorodecaline Notes: Class III; 8/18/
Desc: GasMate Notes: Class III; 8/18/
Desc: Perfluorodecaline Notes: Class III; 8/18/
Desc: Intraocular Silicone Oil Notes: Class III; 8/18/
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Notes: All medical devices class I/II/III
Desc: JALUPRO YOUNG EYE Notes: Class III
Desc: JALUPRO SUPER HYDRO Notes: Class III
Desc: JALUPRO SUPER HYDRO Notes: Class III
Desc: JALUPRO YOUNG EYE Notes: Class III
Desc: Dr Brux mouth guards night guards
Desc: Dr Brux mouth guards night guards
Notes: Mesotherapy Needles and Hypodermic Needles 10/19/
Notes: Mesotherapy Needles and Hypodermic Needles 10/19/
Notes: Mesotherapy Needles and Hypodermic Needles 10/19/
Notes: Sttila Evoluzione Electrical Stimulation Device. 4/12/.
Desc: HCV Real TM Quant Notes: Class III device without a PMA approval
Desc: HCV Real TM Quant Notes: Class III device without a PMA approval
Desc: HBV Real TM Quant Notes: Class III device without a PMA approval
Desc: HBV Real TM Quant Notes: Class III device without a PMA approval
Desc: HCV Real TM Quant Notes: Class III device without a PMA approval
Desc: SARS-CoV-2 Real-TM
Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR)
Desc: AccuraDTect SARS-CoV-2 RT-qPCR Kit
Desc: Sterling Silver Nipple Shield Notes: Class I device without a valid 510k
Desc: STAT-NAT COVID-19 MULTI
Desc: STAT-NAT COVID-19 Positive Control
Notes: Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/
Desc: TUA VISO Non Surgical Facelift Notes: Class II
Desc: TUA VISO Non Surgical Facelift Notes: class II
Desc: Zerosmoke Biomagnets Notes: 9/18/
Desc: Devices Notes: Class II
Notes: Massagers; Muscle Stimulators 4/29/
Notes: Massagers; Muscle Stimulators 4/29/
Notes: Massagers; Muscle Stimulators 4/29/
Notes: Massagers; Muscle Stimulators 4/29/
Notes: Massagers; Muscle Stimulators 4/29/
Notes: Wrinkle Chapeau Condoms. 7/20/
Notes: All devices. DE. "New Health Club" Low Frequency Therapeutic Apparatus Type C
Model HC-32. 8/13/
Desc: ASAPath COVID-19 Antigen Rapid Test (Kit Ref#)
Desc: Lumipulse G SARSCoV-2 Ag-Qual
Notes: Sterilizer; Autoclave 9/17/
Notes: Ceramic Aluminum and Zirconium Balls for Hip Implants 1/13/
Notes: Infant Heel Warmers Infant Crib Warmers 12/27/
Desc: NARL 517 MS (Beauty Equipment Massager) Notes: Class III
Desc: NARL 517 MS (Beauty Equipment Massager) Notes: Class III
Notes: Germanium Pellets Bandages 5/20/ All devices. DE.
Desc: Vitrification Kits
Desc: Acucy SARS-CoV-2 Antigen Test with the Acucy System
Desc: Novel Coronavirus Detection Kit
Desc: Medilift mask
Desc: Medilift eye
Desc: Abaton Far Infrared Massage Bed II Models (800 DX; MS and 800 SA) Notes: Class II
Desc: Asan Easy Test Covid-19 IgG/IgM
Desc: Asan Easy Test Covid-19 IgG/IgM
Desc: Asan Easy Test Covid-19 IgG/IgM
Desc: Absoludy COVID-19 IgM/IgG Combo
Desc: Absoludy COVID-19 IgM/IgG Rapid
Desc: INIST COVID-19 IgM/IgG Rapid
Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application
Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application
Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application
Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application
Desc: REVOLAX
Desc: REVOLAX
Desc: REVOLAX
Desc: Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002
Desc: AQUAGOLD Fine Touch (AQT-001)
Desc: AQUAGOLD Fine Touch (AQT-001)
Desc: Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002
Desc: AQUAGOLD Fine Touch (AQT-001)
Desc: Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002
Desc: MARK-B%u COVID-19 Ag
Desc: BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices) Notes: Class II
Desc: BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices) Notes: Class II
Desc: Tri-M Micro Needle
Desc: Tri-M Micro Needle
Desc: AGE R USSERA DEEP SHOT
Desc: AGE R USSERA DEEP SHOT
Desc: NowCheck COVID-19 Ag Test
Desc: NowCheck COVID-19 Ag Test
Desc: NowCheck COVID-19 Ag Test
Desc: NowCheck COVID-19 IgM/IgG Test
Desc: NowCheck COVID-19 Ag Test
Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)
Desc: ExAmplar COVID-19 real-time PCR kit (L)
Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)
Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)
Desc: AFIAS COVID-19 Ag (with AFIAS- 6 Analyzer)
Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)
Desc: Careclean Personal automatic urine collection system Notes: Class II
Desc: AccuFind COVID19 IgG
Desc: AccuFind COVID19 IgG
Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit
Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit
Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit
Desc: MAYFILL Deep Cross-linked Hyaluronic Acid
Desc: MAYFILL Volume Cross-linked Hyaluronic Acid
Desc: Cross-linked Hyaluronic Acid
Desc: MAYFILL Deep Cross-linked Hyaluronic Acid
Desc: Cross-linked Hyaluronic Acid
Desc: MAYFILL Volume Cross-linked Hyaluronic Acid
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: Revofil Ultra
Desc: Revofil Ultra
Desc: OCimple Light Therapy System Notes: class II
Desc: OCimple Light Therapy System Notes: class II
Notes: Choyand Dana CY Physical Therapy Table; Choyang Dana Muscle Stimulator; Choyang Dana CY Muscle Stimulator; Choyang Dana JO EUN A CIM (Delux Heating Pad) Choyang Dan EUN A CIM (Regular Heating Pad) 4/23/.
Notes: Choyand Dana CY Physical Therapy Table; Choyang Dana Muscle Stimulator; Choyang Dana CY Muscle Stimulator; Choyang Dana JO EUN A CIM (Delux Heating Pad) Choyang Dan EUN A CIM (Regular Heating Pad) 4/23/.
Notes: Choyand Dana CY Physical Therapy Table; Choyang Dana Muscle Stimulator; Choyang Dana CY Muscle Stimulator; Choyang Dana JO EUN A CIM (Delux Heating Pad) Choyang Dan EUN A CIM (Regular Heating Pad) 4/23/.
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS
Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS
Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS
Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: Class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: Class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: AccuFind COVID19 IgG
Desc: Dow QuickFinder -nCoV Real-Time PCR kit
Desc: EDGC RapidCheck COVID-19 IgG Test Kit
Desc: Epithod 616 COVID-19 IgG Test Kit and EDGC RapidCheck COVID-19 IgG Test Kit
Desc: Derma-Q For Microneedle
Desc: Dermapen Needle Notes: The device has no 510(k) clearance or PMA approval
Desc: Derma-Q For Microneedle
Desc: Dermapen Needle Notes: The device has no 510(k) clearance or PMA approval
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device
Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device
Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device
Desc: ULTRAISER; Portable HIFU Machine; Focused Ultrasound Beauty Device
Desc: Contact Lenses Notes: Contacts lenses packaged in plastic clamshell cases (blister packs) are subject to DWPE; glass vials are exempt from DWPE under this listing.
Desc: Contact Lenses Notes: Contacts lenses packaged in plastic clamshell cases (blister packs) are subject to DWPE; glass vials are exempt from DWPE under this listing.
Desc: Skin Stamp Notes: Class II
Desc: Needle; Aspiration And Injection; Disposable Notes: Class III; Vital Injector 2
Desc: Contact lenses Notes: Class II
Desc: Soft cosmetic contact lenses
Desc: Soft cosmetic contact lenses
Desc: Soft cosmetic contact lenses
Desc: Soft cosmetic contact lenses
Desc: Contact Lens Notes: class II/III
Desc: Soft cosmetic contact lenses
Desc: Circle Lenses Notes: Class II; 7/27/
Desc: Soft cosmetic contact lenses
Desc: Soft cosmetic contact lenses
Desc: GENEDIA W COVID-19 Ag
Desc: Leaf Fusion Plasma
Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application
Desc: Leaf Fusion Plasma
Desc: Plaxpot (Model GPX-)
Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application
Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application
Desc: Leaf Fusion Plasma
Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application. DWPE Date: 10/23/
Desc: COVID-19 IgM/IgG
Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR)
Desc: SARS-CoV-2 Real-TM
Desc: AccuraDTect SARS-CoV-2 RT-qPCR Kit
Desc: Mesotherapy Roller Notes: Class II
Desc: Mesotherapy Roller Notes: Class II
Desc: Mesotherapy Roller Notes: Class II
Desc: GENEDIA W COVID-19 Ag
Notes: All devices. GPI = DE. Scalp Vein Infusion Sets.
Desc: SARS-CoV-2 IgG/IgM Antibody Test
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: Contact Lenses
Desc: iLAMP Novel-CoV19 Detection Kit
Desc: Morning Q Ultra Soo 55 contact lenses
Desc: Morning Q Ultra Soo 55 contact lenses
Desc: PolyBone Original (Bone Graft Substitute)
Desc: PolyBone Original (Bone Graft Substitute)
Desc: LabGun COVID-19 ExoFast RT-PCR Kit
Desc: Microneedle Therapy System Notes: Class II
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Notes: All device products; Class I/II/III
Desc: CytoPen Nano Pen
Desc: CytoPen Nano Pen
Desc: Veri-Q COVID-19 Multiplex Assay Kits
Desc: Kairogen covid-19 antigen rapid test
Desc: VERI-Q COVID-19 Ag Rapid Test
Desc: Cross-linked Hyaluronic Acid Notes: Class III
Desc: METOO Fill Deep; Cross-linked Hyaluronic Acid Notes: Class III
Desc: METOO Fill Volume Notes: Class III
Desc: METOO Fill Volume Notes: Class III
Desc: METOO Fill Deep; Cross-linked Hyaluronic Acid Notes: Class III
Desc: Cross-linked Hyaluronic Acid Notes: Class III
Desc: METOO Fill Volume Notes: Class III
Desc: Cross-linked Hyaluronic Acid Notes: Class III
Desc: METOO Fill Deep; Cross-linked Hyaluronic Acid Notes: Class III
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Contact Lenses (Circle Lenses) Notes: Class II
Desc: Meta Duo Beauty Device Notes: Class II
Desc: Meta Duo Beauty Device Notes: Class II
Desc: ND COVID-19 IgG/IgM Rapid Test
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: Contact Lenses Notes: class II; Soft contact lenses, daily wear are not subject to this import alert.
Desc: "RegenOss" Freeze Dried Bone Allograft Notes: Class III; 9/25/
Notes: Nuga Best NM 4/19/
Notes: Nuga Best NM 4/19/
Notes: Nuga Best NM 4/19/
Notes: Nuga Best NM 4/19/
Notes: Nuga Best NM 4/19/
Desc: PCL COVID19 Ag Rapid FIA
Desc: ACCEL ELISA COVID-19
Desc: Contact Lenses Notes: Class 2
Desc: Contact Lenses Notes: class 2
Desc: Contact Lenses Notes: class 2
Desc: Contact Lenses Notes: class 2
Desc: Contact Lenses Notes: class 2
Desc: Contact Lenses Notes: class 2
Desc: Contact Lenses Notes: class 2
Desc: Contact Lenses Notes: class 2
Desc: Contact Lenses Notes: class 2
Desc: Contact Lenses Notes: class 2
Desc: X-Cure skin pricking instrument with needles Notes: Class II;
2/13/
Desc: X-Cure skin pricking instrument with needles Notes: Class II;
2/13/
Desc: X-Cure skin pricking instrument with needles Notes: Class II;
2/13/
Desc: X-Cure skin pricking instrument with needles Notes: Class II;
2/13/
Desc: X-Cure skin pricking instrument with needles Notes: Class II;
2/13/
Desc: X-Cure skin pricking instrument with needles Notes: class II;
2/13/
Desc: Profacial solution
Desc: Sono Machine
Desc: Plasma Machine
Desc: Profacial solution
Desc: Sono Machine
Desc: Plasma Machine
Desc: Sono Machine
Desc: Profacial solution
Desc: Plasma Machine
Desc: Cavi-Lipo Massager Notes: Class III
Desc: Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT
Desc: Cavi-Lipo Massager Notes: Class III
Desc: Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT
Desc: SsmarTest COVID-19 IgM/IgG Detection Kit
Desc: SsmarTest COVID-19 IgM/IgG Detection Kit
Desc: SsmarTest COVID-19 IgM/IgG Detection Kit
Desc: SsmarTest COVID-19 IgM/IgG Detection Kit
Desc: Sonix Whole Body Vibration Machines Notes: Models VM-10, VH-11, and VC-12. Labels and labeling may bear the address of: 1-
125, Wonju Medical Industry Techno Park, -26, Taejang-dong, Wonju-si,
Gangwon-do, Korea.
Desc: Dermapen Notes: class II
Desc: eLIFE Electric Field Health Instrument Notes: Class; II
Desc: Hyperbaric Oxygen Chamber Notes: class II
Desc: Hyperbaric Oxygen Chamber Notes: Class II
Desc: Allplex SARS-CoV- 2/FluA/FluB/RSV Assay (Cat No. RVY; RVX)
Desc: Allplex SARS-CoV- 2/Flu/RSV Assay (Cat No. RVX; RVY)
Notes: Digital Alcohol Detector 8/28/
Desc: Iontophoresis device for non-CF diagnosis (Skin care appliance) Notes: Class II
Desc: Iontophoresis device for non-CF diagnosis (Skin care appliance) Notes: Class II
Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II
Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II
Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II
Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II
Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II
Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II
Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II
Desc: SD Bioline HIV 1/2 3/0 test kit Notes: class II
Desc: SGTi-flex COVID-19 Ag
Desc: TCM-Q Corona III Kit
Desc: Air Queen Nano Mask
Desc: Nano Mask
Desc: Mesotherapy Roller Notes: Class II
Desc: Mesotherapy Roller Notes: Class II
Desc: Mesotherapy Roller Notes: Class II
Desc: All Contact Lenses Notes: Class II ; III
Desc: All Contact Lenses Notes: Class II; III
Desc: Callas Charming Double Eyelid Tape
Desc: Callas Charming Double Eyelid Tape
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: Class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Notes: All devices. DWI=DE. Heparin Lock (PRN) Protected Needle Adaptor(PNA)IV In-
Line Connector Multiple Sample Luer Adaptor. 3/5/.
Desc: Contact Lens Notes: class II/III
Desc: VISS Sonic Microdermabrasion Machine Notes: Class II
Desc: VISS Sonic Microdermabrasion Machine Notes: Class II
Desc: iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Notes: All medical devices; class II
Desc: Morning Life Compression Limb Therapy System Notes: Class II device without a valid 510k
Desc: MolecuTech Real- Time COVID-19
Desc: MolecuTech Real- Time COVID-19
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
Desc: RAPID TEST KIT
Desc: COVID-19 Ag RDT Test Kit
Desc: ANW COVID-19 Ag RDT Test Kit
Desc: Isabella Therapeutic Massage Mat Notes: Class II
Desc: Peni Master Pro Device
Desc: Peni Master Pro Device
Desc: Peni Master Pro Device
Desc: Peni Master Pro Device
Desc: PRORAPID KIT CORONAVIRUS DISEASE (SARS-COV-2) IGG/IGM RAPID TEST CASSETTE SINGLE USE KIT Notes: Class III device, requires 510(k), or de novo application
Desc: PRORAPID KIT CORONAVIRUS DISEASE (SARS-COV-2) IGG/IGM RAPID TEST CASSETTE SINGLE USE KIT Notes: Class III device, requires 510(k), or de novo application
Desc: PRORAPID KIT CORONAVIRUS DISEASE (SARS-COV-2) IGG/IGM RAPID TEST CASSETTE SINGLE USE KIT Notes: Class III device, requires 510(k), or de novo application
Desc: PRORAPID KIT CORONAVIRUS DISEASE (SARS-COV-2) IGG/IGM RAPID TEST CASSETTE SINGLE USE KIT Notes: Class III device, requires 510(k), or de novo application
Notes: New Fill Poly Lactic Implant (Dermal Implant for Aesthetic Use) 4/9/
Desc: ACCO COVID-19 IgM/IgG TEST
Desc: ACCO COVID-19 IgM/IgG TEST
Desc: ACCO COVID-19 IgM/IgG TEST
Notes: Latext patient Examination Gloves
Desc: Pelican COVID-19 Ultra-Rapid Mobile Test for At-Home Testing
Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black
Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black
Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black
Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black
Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black
Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Notes: All devices; Class II/III
Desc: Supermax Nitrile Gloves
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test
Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test
Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test
Desc: (COVID-19) (Sars-Cov-2) IgG/IgM Immunochromatographic Antibody Test
Desc: Contact lenses
Desc: Contact lenses
Desc: Contact lenses
Desc: Contact lenses
Desc: Contact lenses
Desc: Contact lenses Notes: 2/3/
Desc: Contact lenses
Desc: Contact lenses
Desc: Monthly Silicone Hydrogel Soft Contact Lenses
Desc: Penis Extender Notes: Class II
Desc: Penis Extender Notes: class II
Desc: Penis Extender Notes: Class II
Desc: Penis Extender Notes: class II
Desc: Lamp; Infrared; Therapeutic Heating Notes: class II
Manufacturer: Health Technology (Pty) Ltd, FEI #
Desc: Stimulator; Muscle; Powdered; For Muscle Conditioning Notes: class II
Manufacturer: Health Technology (Pty) Ltd, FEI #
Notes: Little Sentry Junior Monitor 6/29/
Desc: Acupuntador Notes: class II;
8/30/
Desc: Thermofleet Blanket Notes: Class II
Please examine labeling for MRI use/compatibility/�MR conditional". If the
product does not contain the MRI labeling, please release the product. However
if it does, please do not release the product pending guidance from DIOP or
CDRH.
Desc: Thermofleet Blanket Notes: Class I
Please examine labeling for MRI use/compatibility/�MR conditional". If the
product does not contain the MRI labeling, please release the product. However
if it does, please do not release the product pending guidance from DIOP or
CDRH.
Desc: Thermofleet Blanket Notes: Class II
Please examine labeling for MRI use/compatibility/�MR conditional". If the
product does not contain the MRI labeling, please release the product. However
if it does, please do not release the product pending guidance from DIOP or
CDRH.
Desc: Thermofleet Blanket Notes: Class I
Please examine labeling for MRI use/compatibility/�MR conditional". If the
product does not contain the MRI labeling, please release the product. However
if it does, please do not release the product pending guidance from DIOP or
CDRH.
Desc: Exa SARS- CoV-2 Rapid Antigen Test
Notes: HIV 1/2 Whole Blood Test Kit. 11/9/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Notes: HIV 1/2 Whole Blood Test Kit. 11/9/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: Meta-Ject FX50
Desc: Advanced Glycation Endproduct Notes: class II
Desc: Advanced Glycation Endproduct Notes: class II
Desc: OBSERV 520X; 520X BEAUTY TOOL
Desc: OBSERV 520X; 520X BEAUTY TOOL
Desc: OBSERV 520X; 520X BEAUTY TOOL
Desc: BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502)
Desc: Biozek COVID-19 Antigen Rapid Test Cassette
Desc: Biozek Antigen Rapid Test
Desc: BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502)
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Manuka Magic Skin Care Cream
Desc: Manuka Magic Skin Care Cream
Desc: Circumcision Clamps Notes: 5/17/
Notes: 5/17/ Circumcision Clamps.
Desc: Contact lens cases
Desc: Contact lens cases
Desc: Case; Contact Lens
Desc: Case; Contact Lens
Desc: Case; Contact Lens
Desc: Case; Contact Lens
Desc: All dermal filler and injectable hyaluronic acid products
Desc: All dermal filler and injectable hyaluronic acid products
Desc: All dermal filler and injectable hyaluronic acid products
Desc: All dermal filler and injectable hyaluronic acid products
Desc: Sleep Mask
Desc: Sleep Mask
Desc: BiologyWorks k(now) COVID-19 Molecular Test
Desc: Egyptian Healing Rods Notes: Class III
Desc: Egyptian Healing Rods Notes: Class II
Desc: Fralov's Respiration Training Devices Notes: Class II
Desc: Hair Probe; Healing Blanket; Electrode Belt; Paravertebral Pawns; Cosmetiological Probe Notes: Class II
Desc: abTES%u COVID-19 qPCR Kit
Desc: RESOLUTE 2.0 SARS-CoV-2 Detection Assay
Desc: -nCoV IgG/IgM Detection Kit (Colloidal Gold)
Desc: -nCoV IgG/IgM Detection Kit (Colloidal Gold)
Desc: -nCoV IgG/IgM Detection Kit (Colloidal Gold)
Desc: Smart Covid-19 Igm/IgG RDT Notes: Class III device, requires 510(k), or de novo application
Desc: Quiz SARS-CoV-2 NAT System
Desc: Smart Covid-19 Igm/IgG RDT Notes: Class III device, requires 510(k), or de novo application
Desc: Smart Covid-19 Igm/IgG RDT Notes: Class III device, requires 510(k), or de novo application
Desc: Smart Covid-19 Igm/IgG RDT Notes: Class III device, requires 510(k), or de novo application
Desc: VitaPCR Instrument -VitaPCR SARS-CoV-2 Gen 2 Assay
Desc: VitaPCR SARS-CoV-2 Gen2 External Control Set
Desc: BioWalker SARS- CoV-2 Assay 2.0
Notes: OraScreen HIV Rapid Test Kits 8/13/ HIV Diagnostic Kits are
Class III devices within the meaning of Section 513(f)(1) of the Act
and are regulated by CBER under the current intercenter agreement
between CDRH and CBER. The unapproved diagnostic test kits claim to
detect HIV antibodies in blood or saliva and provide results in the
home in 15 minutes or less. The test kits are imported into the US
through the mail and may be entered as Asamples@ or for Apersonal
usa@. The contents may be labeled Afor investigational use@ for
Aresearch use@ or Afor export only @. The test kits could present a
serious hazard to the public health; including possible HIV
transmission to partners and delayed access to medical care due to
mis-diagnosed false negative tests. If entries are encounted;
contact CBER Import/Export team at 301-827-.
Notes: Helico Blot 2.0; 8/13/
Desc: HEV IgM. ELISA Notes: 8/13/
Desc: iCare HIV 1&2 Rapid Screen Test
Desc: iCare One-Step HIV 1/2 Oral Fluid Test
Desc: iCare HIV 1&2 Oral Swab Rapid Screen Test
Desc: iCare HIV 1&2 Oral Swab Rapid Screen Test
Desc: iCare HIV 1&2 Rapid Screen Test
Desc: iCare One-Step HIV 1/2 Oral Fluid Test
Desc: iCare One-Step HIV 1/2 Oral Fluid Test
Desc: iCare HIV 1&2 Rapid Screen Test
Desc: iCare HIV 1&2 Oral Swab Rapid Screen Test
Desc: MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test
Desc: MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test
Desc: MiRXES Fortitude SARS-CoV-2 & FluA/B Test
Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/
Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/
Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/
Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/
Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/
Notes: Blood Pressure Monitors Massagers Muscle Stimulators; Class III; 4/29/
Desc: Blood Pressure Monitors Massagers Muscle Stimulators Notes: Class III; 4/29/
Desc: SARS-CoV-2 IgM/IgG Testing Kit
Desc: SARS-CoV-2 IgM/IgG (GICA) Test
Desc: Genabio SARS-CoV-2 IgM/IgG Testing Kit
Desc: Covid-19 Rapid IgG/IgM Combined Antibody Assay Pre-Screening Kit Notes: Class III device, requires 510(k), or de novo application
Desc: Covid-19 Rapid IgG/IgM Combined Antibody Assay Pre-Screening Kit Notes: Class III device, requires 510(k), or de novo application
Desc: Covid-19 Rapid IgG/IgM Combined Antibody Assay Pre-Screening Kit Notes: Class III device, requires 510(k), or de novo application
Desc: Covid-19 Rapid IgG/IgM Combined Antibody Assay Pre-Screening Kit Notes: Class III device, requires 510(k), or de novo application
Desc: ViroKey Flu A/B & RSV RT-PCR Extension Kit (For use with ViroKey SARS-CoV-2 RT-PCR Test v2;0) pin
Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka
HIV/AIDS test kit) 1/29/. HIV Diagnostic Kits are Class III
devices within the meaning of Section 513(f)(1) of the Act and are
regulated by CBER under the current intercenter agreement between
CDRH and CBER. The unapproved diagnostic test kits claim to detect
HIV antibodies in blood or saliva and provide results in the home in
15 minutes or less. The test kits are imported into the US through
the mail and may be entered as Asamples@ or for Apersonal usa@. The
contents may be labeled Afor investigational use@ for Aresearch use@
or Afor export only @. The test kits could present a serious hazard
to the public health; including possible HIV transmission to
partners and delayed access to medical care due to mis-diagnosed
false negative tests. If entries are encounted; contact CBER
Import/Export team at 301-827-.
Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka HIV/AIDS test kit) 1/29/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Notes: HIV 2 Blood Test Kit 5/25/ HIV Diagnostic Kits are Class III
devices within the meaning of Section 513(f)(1) of the Act and are
regulated by CBER under the current intercenter agreement between
CDRH and CBER. The unapproved diagnostic test kits claim to detect
HIV antibodies in blood or saliva and provide results in the home in
15 minutes or less. The test kits are imported into the US through
the mail and may be entered as Asamples@ or for Apersonal usa@. The
contents may be labeled Afor investigational use@ for Aresearch use@
or Afor export only @. The test kits could present a serious hazard
to the public health; including possible HIV transmission to
partners and delayed access to medical care due to mis-diagnosed
false negative tests. If entries are encounted; contact CBER
Import/Export team at 301-827-.
Notes: HIV 2 Blood Test Kit 5/25/ HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS- CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS- CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ; ;
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS- CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ; ;
Desc: Environ DF II Sonophoresis & Iontophoresis Facial Machine (Ionzyme DF II) Notes: Class II device without a valid 510k
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS- CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;
Desc: HIV Test Kit Notes: Class III; 9/18/
Desc: HIV Test Kit Notes: Class III; 9/18/
Desc: HIV Test Kit Notes: Class III; 9/18/
Desc: HIV Test Kit Notes: Class III; 9/18/
Desc: HIV Test Kit Notes: Class III; 9/18/
Desc: HIV Test Kit Notes: Class III; 9/18/
Desc: Lamp; Infrared; Therapeutic Heating Notes: class II
Distributor: Esparron Limited, FEI #
Desc: Stimulator; Muscle; Powdered; For Muscle Conditioning Notes: class II
Distributor: Esparron Limited, FEI #
Desc: -nCoV IgG/IgM Rapid Test Cassette
Desc: -nCoV IgG/IgM Rapid Test Cassette
Desc: -nCoV IgG/IgM Rapid Test Cassette
Desc: Lens; Spectacle; Non-Custom (Prescription) Notes: No 510K
Desc: Frame; Spectacle Notes: No 510K
Desc: COVID-19 IgM/IgG Lateral Flow Assay
Desc: COVID-19 IgM/IgG Lateral Flow Assay
Desc: COVID-19 IgM/IgG Lateral Flow Assay
Desc: COVID-19 IgM/IgG Lateral Flow Assay
Desc: COVID-19 IgM/IgG Lateral Flow Assay
Desc: COVID-19 IgM/IgG Lateral Flow Assay
Desc: Sanitoets Urine test strips Notes: Class II
Desc: Sanitoets Prostate Home test Notes: Class III
Desc: Sanitoets Malaria home test Notes: Class II
Desc: Sanitoets Urine Test Strips Notes: Class II
Desc: Sanitoets Prostate home test Notes: Class III
Desc: Sanitoets Malaria Home test Notes: Class II
Desc: Sanitoets Urine test strips Notes: Class II
Desc: Sanitoets Prostate home Test Notes: Class III
Desc: Sanitoets Malaria Home test Notes: Class II
Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka
HIV/AIDS test kit) 1/29/. HIV Diagnostic Kits are Class III
devices within the meaning of Section 513(f)(1) of the Act and are
regulated by CBER under the current intercenter agreement between
CDRH and CBER. The unapproved diagnostic test kits claim to detect
HIV antibodies in blood or saliva and provide results in the home in
15 minutes or less. The test kits are imported into the US through
the mail and may be entered as Asamples@ or for Apersonal usa@. The
contents may be labeled Afor investigational use@ for Aresearch use@
or Afor export only @. The test kits could present a serious hazard
to the public health; including possible HIV transmission to
partners and delayed access to medical care due to mis-diagnosed
false negative tests. If entries are encounted; contact CBER
Import/Export team at 301-827-.
Desc: Sanitoets Urine Test Strips Notes: Class II
Desc: Sanitoets Prostate Home Test Notes: Class III
Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka HIV/AIDS test kit) 1/29/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: Sanitoets Malaria Home test Notes: Class II
Desc: Sanitoets Urine test strips Notes: Class II
Desc: Sanitoets Prostate home test Notes: Class III
Desc: Sanitoets Malaria Home test Notes: Class II
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ;
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.
Desc: OTOSTICK Notes: 21 CFR 878. (External aesthetic restoration prosthesis) is the most
appropriate device classification for this product.
The labeling for Otostick states that it is an "ear correction device" for which "some adaptation time may be required" and "correct adaptation without any discomfort will be progressively achieved." The labeling also states "corrects excessive prominence of the ears." The intended use appears to cause structure change to the placement of the ears.
Desc: OTOSTICK Notes: 21 CFR 878. (External aesthetic restoration prosthesis) is the most
appropriate device classification for this product.
The labeling for Otostick states that it is an "ear correction device" for which "some adaptation time may be required" and "correct adaptation without any discomfort will be progressively achieved." The labeling also states "corrects excessive prominence of the ears." The intended use appears to cause structure change to the placement of the ears.
Desc: HR3 Cap Notes: Class II device without a valid 510(k).
Desc: Presojet Pressure Massage Notes: Class II device without a valid 510(k).
Desc: Hook of Sweden Trigger Point Massager Notes: Class II
Notes: BD OPtima Birthing Bed (10/27/) BD Optima Birthing Bed (10/27/)
Desc: Derma Fillers
Desc: Derma Fillers
Desc: Derma Fillers
Desc: Derma Fillers
Desc: Derma Fillers
Desc: Derma Fillers
Desc: Derma Fillers
Desc: Derma Fillers
Desc: Derma Fillers
Desc: Derma Fillers
Desc: Cederroth Breathing Mask Notes: Class II
Desc: Perlane Sodium Hyaluronic Acid Notes: 6/3/
Notes: All devices 11/21/ DWI = DE
Notes: 11/21/ All devices DWI = DE.
Desc: GDx GrandPerformance SARS-CoV-2 Detection Kit
Desc: TATAA GrandPerformance SARS-CoV-2 Detection Kit
Desc: Percutaneous Catheter; M CATH FLEXY
Desc: Bloom COVID-19 Test
Notes: All devices. DWI = DE. Belimed Washing Machine Model SM 700 (3/5/) Belimed
Scope Washing Machine Model SME (3/5/) Belimed Washington Machine
Midel SM (3/5/)
Desc: Glass bead sterilizers Notes: Class III
Notes: Elecsys HBsAg Immunoassay Kits 11/26/
Notes: Compex 2 Iontophotoresis.
Notes: All devices. GPI = DE. Endoclean and Decontaminating Machines Models LS--
850 LS-76 DW/T-216
Notes: Evoked Response Electrical Stimulator 5/25/
Desc: Zepter Cosmetics Electro-Acupuncture Device 12/3/ Notes: 12/3/
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All Devices
Notes: All devices. GPI=DE. 4/20/.
Notes: Orbasone TM; aka Orbasone Therpeutic Vibrator and Ossanol TM; aka Ossanol Therapeutic Vibrator. 6/29/
Desc: Liposuction Machine; LipoSurg Notes: Class II device, requires 510(k), or de novo application.
Desc: Liposuction Machine; LipoSurg Notes: Class II device, requires 510(k), or de novo application.
Desc: Liposuction Machine; LipoSurg Notes: Class II device, requires 510(k), or de novo application.
Desc: JALUPRO SUPER HYDRO Notes: Class III
Desc: JALUPRO YOUNG EYE Notes: Class III
Desc: JALUPRO YOUNG EYE Notes: Class III
Desc: JALUPRO SUPER HYDRO Notes: Class III
Desc: CCL Vario Demo For Trade Show
Desc: CCL 365 Corneal Cross-Linking System
Desc: CCL 365 Vario Ultraviolet Lamp
Desc: Phoenix Demo for Trade Show
Desc: CCL Vario Demo Unit;
Desc: UV Lamp
Desc: CCL Vario Demo For Trade Show
Desc: Phoenix Demo for Trade Show
Desc: CCL Vario Demo Unit
Desc: CCL 365 Vario Ultraviolet Lamp
Desc: CCL 365 Corneal Cross-Linking System
Desc: CCL Vario Demo For Trade Show
Desc: CCL 365 Vario Ultraviolet Lamp
Desc: CCL 365 Corneal Cross-Linking System
Desc: CCL Vario Demo Unit
Desc: Phoenix Demo for Trade Show
Desc: UV Lamp
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: Implantable Device Notes: DWPE Date; 4/23/
Desc: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Desc: COVID-19 Rapid IgM/IgG Combined Antibody Assay
Desc: Spring COVID-19 IgM/IgG Rapid Test Cassette
Desc: D-Actor 50 Shockwave device Notes: Class III
Desc: EXAGON MAT
Desc: iMRS Basic
Desc: EXAGON Brain
Desc: iMRS Expert
Desc: EXAGON SENSE
Desc: iMRS Hybrid
Desc: EXAHGON FIR MAT
Desc: iMRS Advanced
Desc: EXAGON SPOT
Desc: EXAGON SENSE
Desc: EXAGON SPOT
Desc: EXAHGON FIR MAT
Desc: EXAGON MAT
Desc: iMRS Hybrid
Desc: EXAGON Brain
Desc: iMRS Basic
Desc: iMRS Advanced
Desc: iMRS Expert
Desc: The Bloom Lab
Desc: TEOSYAL PureSense Deep Lines
Desc: TEOSYAL PureSense Ultra Deep
Desc: TEOSYAL PureSense Global Action
Desc: SARS-CoV-2 IgG/IgM Rapid Test
Desc: ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test
Desc: ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test
Desc: COVID-19 Viral Antigen Rapid Test
Desc: COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)
Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)
Notes: Pacifier Thermometer 3/9/
Desc: New Clave Autohouse AD& (Non-Vacuum Type) Notes: Class II, AD7
Desc: GeneOne COVID-19 Nucleic Acid Diagnostic Kit
Desc: EASE BN-96 Notes: Problem; Class III Device
Desc: GB SARS-CoV-2 Real-Time RT-PCR
Desc: GB SARS-CoV-2 Ab ELISA
Desc: GB SARS-CoV-2 Real-Time RT-PCR
Desc: POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent
Desc: Acupuncture Massager
Desc: iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva
Desc: iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva
Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)
Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)
Desc: Glass Eye Wash Cup Notes: Class II
Desc: Glass Eye Wash Cup Notes: Class II
Notes: All devices. 2/1/ LYM-03 Terminator Mini-Electrical Syringe Needle
Destroyer.
Desc: LabTurbo AIO COVID-19 RNA Testing Kit
Desc: Nasal Relief Pinguin
Desc: M-399 Diamond Peel Dematome; Massager Notes: Class II
Desc: Vstrip COVID-19 Antigen Rapid Test
Desc: Sun Eeze (Gtsrite) protective eye wear Notes: 10/14/
Desc: Skin tag Removal kit Notes: Class I device without a valid 510K
Desc: VTRUST COVID-19 Antigen Rapid Test
Desc: LabTurbo AIO COVID-19 RNA Testing Kit
Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device Notes: Class III
Desc: T.E.N.S. Pro 900 Energy Point Stimulator Notes: Class III
Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device Notes: Class III
Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device Notes: Class III
Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device Notes: Class III
Notes: Pacifier Thermometer 3/9/. >>> Lumiscope Inc. 400 Raritan Center Pkwy. Edison; NJ << Trade Name Lumiscope Baby Therm
Notes: HIV Test Kits. 2/24/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Notes: HIV Test Kits. 2/24/. HIV Diagnostic Kits are Class III devices
within the meaning of Section 513(f)(1) of the Act and are regulated
by CBER under the current intercenter agreement between CDRH and
CBER. The unapproved diagnostic test kits claim to detect HIV
antibodies in blood or saliva and provide results in the home in 15
minutes or less. The test kits are imported into the US through the
mail and may be entered as Asamples@ or for Apersonal usa@. The
contents may be labeled Afor investigational use@ for Aresearch use@
or Afor export only @. The test kits could present a serious hazard
to the public health; including possible HIV transmission to
partners and delayed access to medical care due to mis-diagnosed
false negative tests. If entries are encounted; contact CBER
Import/Export team at 301-827-.
Notes: PainNOT Infrared Heating PAD 5/12/
Notes: PainNOT Infrared Heating Pad 5/12/
Desc: Skeen Patch
Desc: Skeen Patch
Notes: Foot Choice Vibrating Heat Massager w/Infrared Heat 5/12/
Notes: Foot Choice Vibrating Heat Massager w/Infrared Heat 5/12/
Desc: Loss of Resistance Syringe (Glass)
Desc: Nitrile Examination Glove Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.
Desc: Nitrile Examination Glove Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.
Desc: Nitrile Examination Glove Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.
Desc: Nitrile Examination Glove Notes: Class 1. Providing 510(k) may not be sufficient to overcome the appearance of violation.
Desc: CHIL COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/serum/Plasma)
Desc: CHIL COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/serum/Plasma)
Desc: The ErkimCOVID-19 SARS-CoV-2 iRAMP Diagnostic Kit
Desc: Sentebiolab Senteligo SARS- CoV-2 (COVID-19) Multiplex qPCR Detection Kit
Desc: CRT (COVID-19 RAPID TEST)
Desc: CRT (COVID-19 RAPID TEST)
Desc: CRT (COVID-19 RAPID TEST)
Desc: CRT (COVID-19 RAPID TEST)
Desc: Cirrus COVID-19IgM/IgG Antibody Test
Desc: Cirrus Serological IgGand IgM Test
Desc: Toyo SARS-CoV-2 IgM/IgG Ab Test
Desc: Info SARS-CoV-2 IgM/IgG Ab Test
Notes: Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/.
Desc: Vivoo Test Strips Notes: Class II device that requires 510(k) clearance
Desc: Laser Vision Glasses (Pinhole glasses) Notes: 02/6/08
Desc: Laser Vision Glasses (Pinhole glasses) Notes: 02/6/08
Notes: ENART a Tens Device 2/6/ Claims related to disorders of the Central Nervous System; the Peripheral Nervous Systm; the Respiratory system; ect. as well as dental diseases
Desc: Arbor Test-Microscope for Regulation of Pregnancy Notes: 3/16/
Desc: SYNVISC ONE
Desc: Euflexxa 1% Sodium Hyaluronate
Desc: Pulse Guard Package Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.
Desc: Pulse Guard Package Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.
Notes: Obstetric TENS Unit (Abby TENS) 5/15/.
Desc: AbC-19 Rapid Test
Desc: Sona Nanotech COVID-19 LFA
Desc: Hyaluronic Acid
Desc: Insulin Pump Case
Desc: Insulin Pump Case
Desc: Stimulator Electro-Acupuncture Notes: Class III
Desc: GastroCHECK Gastrolyzer
Desc: Flexpulse
Desc: GastroCHECK Gastrolyzer
Desc: GastroCHECK Gastrolyzer
Desc: Flexpulse
Desc: Flexpulse
Desc: BioSURE COVID-19 IgG Antibody Rapid Test
Desc: BioSURE COVID-19 Antibody Rapid Test
Desc: BioSURE COVID-19 Antibody Self Test
Desc: TENS Elite; Profile TENS; TENS N Tone; TENS Elite Dual Lead; Lady TENS; 804-OB Obstetric TENS Unit (Abby TENS) Notes: Class III; 5/15/
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Liquid Silk; Sensual Lubricant
Desc: Lipodren Muscle Stimulator Notes: DWPE Date 7/20/
Desc: Lipodren Muscle Stimulator Notes: DWPE Date 7/20/
Desc: Lipodren Muscle Stimulator Notes: DWPE Date 7/20/
Desc: Lipodren Muscle Stimulator Notes: DWPE Date 7/20/
Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III
Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III
Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III
Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III
Desc: SaliVIR Rapid Multiplex COVID19 vRNA Test
Desc: SaliVIR OME Collection kit
Desc: ElectraStim Electro Stimulator Notes: Class II
Desc: ElectraStim Electro Stimulator Notes: class II
Desc: ElectraStim Electro Stimulator Notes: class II
Desc: CovidNudge
Desc: DnaNudge CovidNudge COVID-19
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Blue X-Ray Plaster/Strips (Bandages)
Desc: Blue X-Ray Plaster/Strips (Bandages)
Desc: Blue X-Ray Plaster/Strips (Bandages)
Desc: Contact Lenses & Decorative Contact Lenses Notes: Class II Device
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Hyaluronic Acid
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Notes: All medical devices
Desc: Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT)
Desc: Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Desc: Anti Snoring Ring Notes: 12/22/
Desc: Anti Snoring Ring
Desc: bKIT Virus Finder COVID-19
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Desc: Ionithermie Machine Notes: class II
Desc: Ionithermie Machine Notes: class II
Desc: Ionithermie Machine Notes: class II
Desc: Ionithermie Machine Notes: class II
Desc: Ionithermie Machine Notes: Class II
Desc: Ionithermie Machine Notes: Class II
Desc: Ionithermie Machine Notes: Class II
Desc: Ionithermie Machine Notes: Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: 3/13/ Training Materianls; Introductory Training; Level 1 Training; Level 2 Training; Eliminating Electromagnetic Stress From Your Life. Skenar (Self Controlled-Neuro-Adpative Regulator) The NEW Life-Energies Skenar 97.4
Notes: 3/13/ Pocket Skenar Large Energiser Healing Blanket; Medium Energiser
Healing Blanket; Small Energiser Healing Blanket; Cell-O-Matt Kit Computer
Cleare
Desc: BioSURE COVID-19 IgG Antibody Rapid Test
Desc: BioSURE COVID-19 Antibody Self Test
Desc: BioSURE COVID-19 Antibody Rapid Test
Desc: Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT)
Desc: Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III
Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III
Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III
Notes: Beauty Massge Tools (Microdermabrader Quantum CACI MK2/Ultra Screen To; Hydratone Face Rollers; Ultrasonic handsets); Class III
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Contact lenses Notes: class II
Desc: Omega VISITECT COVID-19 Antigen Rapid Diagnostic Test (RDT)
Desc: Global Access Diagnostics (GAD) COVID-19 Antigen Rapid Diagnostic Test
Desc: Synergy Eye Massager
Desc: Synergy Face Massager
Desc: Synergy Eye Massager
Desc: Synergy Face Massager
Desc: Synergy Neck Massager Model BP-
Desc: Synergy Eye Massager
Desc: Synergy Face Massager
Desc: Synergy Neck Massager Model BP-
Desc: Synergy Eye Massager
Desc: Synergy Eye Massager
Desc: Synergy Face Massager
Desc: Synergy Face Massager
Desc: Synergy Eye Massager
Desc: Synergy Eye Massager
Desc: Synergy Eye Massager
Desc: Synergy Face Massager
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: "I clean" antibacterial contact lens soaking case 9/3/
Desc: T cell ELISPOT test for SARS-CoV-2
Desc: T-SPOT.COVID
Desc: Hyaluronic Acid; EUFLEXXA; Sodium Hyaluronate
Desc: Hyaluronic Acid; EUFLEXXA; Sodium Hyaluronate
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Contact Lenses Notes: class II
Desc: Cock Ring Notes: Class II
Desc: Penis Extender Notes: Class II
Desc: Breast Pump Notes: Class II
Desc: Breast Pump Notes: Class II
Desc: Penis Extender Notes: class II
Desc: Cock Ring Notes: Class II
Desc: Breast Pump Notes: Class II
Desc: Breast Pump Notes: class II
Desc: Pulse Guard Package Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.
Desc: Pulse Guard Package Notes: Class II device that requires 510(k) clearance and it is regulated under 21 CFR 882.
Notes: 7/15/ Tinnitus Maskers
Desc: Stimulator Electro-Acupuncture Notes: Class III
Desc: Smilegems Temporary Tooth Jewels Notes: Class II
Notes: "i-clean" antibacterial contact lense soaking case
9/3/
Notes: Omnivir Device Possibly listed as oxygen generator 12/17/
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: Contact Lenses Notes: Class II
Desc: INSTAsmile Clip/Tooth Cove Notes: Class II device
Desc: INSTAsmile Clip On Venners Notes: Class II device
Desc: INSTAsmile Clip On Venners Notes: Class II device
Desc: INSTAsmile Clip/Tooth Cove Notes: Class II device
Desc: INSTAsmile Clip On Venners Notes: Class II device
Desc: INSTAsmile Clip/Tooth Cove Notes: Class II device
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Notes: Massager; Class II
Desc: Personal Contraceptive Monitor Notes: Shipper for Unipath Ltd.; 2/5/
Desc: Hydromax Penis Pump
Desc: Hercules Penis Pump
Desc: Hercules Penis Pump
Desc: Hydromax Penis Pump
Desc: Penis Pump Notes: Class III
Desc: Personal Contraceptive Monitor Notes: 2/5/
Notes: Ion Magnum IV Body and Face Medical Device (Trade names Ion Genius; Forever Young Arasys Perfector; Ion research; Ion Medica and Ion Magnum); Class II
Notes: Ion Magnum IV Body and Face Medical Device (Trade names Ion Genius; Forever Young Arasys Perfector; Ion research; Ion Medica and Ion Magnum); Class II
Desc: Magnessage Device Notes: Lacks 510(K)
Desc: Food Intolerance Testing Kits Notes: Class II device without a valid 501K
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Color Contact Lenses Notes: class II
Desc: Hyaluronic Acid
Desc: Micro current beautiful Image Facial and Body Sculpting Notes: class II
Desc: Micro current beautiful Image Facial and Body Sculpting Notes: class II
Notes: Importer of Record for PAP-IMI Ion Magnetic Conductor Device Unclassified Industry Code 84. 1/13/
Desc: Massager Notes: Rhino Roller; Class II
Desc: Hyaluronic Acid
Notes: HIVSCAN 1 2 Kit (Human Immunodeficiency Virus HIV-1 & HIV02 Test
Kit) 10/28/. HIV Diagnostic Kits are Class III devices within
the meaning of Section 513(f)(1) of the Act and are regulated by
CBER under the current intercenter agreement between CDRH and CBER.
The unapproved diagnostic test kits claim to detect HIV antibodies
in blood or saliva and provide results in the home in 15 minutes or
less. The test kits are imported into the US through the mail and
may be entered as Asamples@ or for Apersonal usa@. The contents may
be labeled Afor investigational use@ for Aresearch use@ or Afor
export only @. The test kits could present a serious hazard to the
public health; including possible HIV transmission to partners and
delayed access to medical care due to mis-diagnosed false negative
tests. If entries are encounted; contact CBER Import/Export team at
301-827-.
Notes: HIVSCAN 1 2 Kit (Human Immunodeficiency Virus HIV-1 & HIV02 Test Kit) 10/28/. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-.
Desc: Hyaluronic Acid
Desc: Bio Hydroderm V2 Microderm Abrasion units Notes: class II
Desc: Bio Synthesis Light activated Notes: class II
Desc: Bio Hydroderm Hydrodermabrasion System Notes: class II
Desc: Bio Synthesis Light activated Notes: Class II
Desc: Bio Hydroderm Hydrodermabrasion System Notes: Class II
Desc: Bio Hydroderm V2 Microderm Abrasion units Notes: Class II
Desc: Bt-Micro Dermabrasion Unit Notes: class II
Desc: Bt-Micro Dermabrasion Unit Notes: class II
Desc: Medical Extender Andro Penis Extender Notes: Class II
Lacks 510(K)
Desc: Trueline COVID-19 IgG/IgM Rapid Test
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