Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Gurunanda, LLC
H3200
In Commercial Distribution

  • 00810051084634 ()


  • Oral lavage system
Battery powered rechargeable flosser
Gurunanda, LLC
H100
In Commercial Distribution

  • 00810051083941 ()


  • Oral lavage system
Water Irrigator rose gold color
Supermouth LLC
12000025
In Commercial Distribution

  • 00810131041311 ()


  • Oral lavage system
Water Irrigator bluecolor
Supermouth LLC
12000024
In Commercial Distribution

  • 00810131041304 ()


  • Oral lavage system
Water Irrigator white color
Supermouth LLC
12000023
In Commercial Distribution

  • 00810131041298 ()


  • Oral lavage system
No Description
Shenzhen Hanasco Technology Co., Ltd.
Model# 5430
In Commercial Distribution

  • 06971481859774 ()


  • Oral lavage system
No Description
Shenzhen Hanasco Technology Co., Ltd.
Model# 5447
In Commercial Distribution

  • 06971481851051 ()


  • Oral lavage system
The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. 510K Cleared for Professional Use Only.
CHEMATICS, INC.
43001
In Commercial Distribution

  • 00737051548327 ()
  • 00737051548310 ()
  • 00737051548303 ()


  • Multiple lipid analyte IVD, kit, colorimetric, rapid, professional/self-test
Rechargable electric toothbrush with high density bristles. 1 Sonic handle, 2 brush heads, and charging base and cable. Pink color
PRACTICON, INC.
7155010 PIN
In Commercial Distribution

  • 00723896018750 ()
  • 00723896018743 ()
7155010 PIN

  • Ionic electric toothbrush
Rechargable electric toothbrush with high density bristles. 1 Sonic handle, 2 brush heads, and charging base and cable. White color
PRACTICON, INC.
7155010 WHI
In Commercial Distribution

  • 00723896018736 ()
  • 00723896018729 ()
7155010 WHI

  • Ionic electric toothbrush
Air and Water Syringe tips for Dental Procedures
PRACTICON, INC.
701791
In Commercial Distribution

  • 00723896018576 ()
  • 00723896018569 ()
  • 00723896018552 ()
701791

  • Oral lavage system
Rechargable electric toothbrush with high density bristles. 1 Sonic handle, 2 brush heads, and charging base and cable. Black color
PRACTICON, INC.
7155010 BLA
In Commercial Distribution

  • 00723896018712 ()
  • 00723896001936 ()
7155010 BLA

  • Ionic electric toothbrush
1T,EN,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H A3218
In Commercial Distribution

  • 06936983149426 ()
ID-AT1-DIP-FEN-1-AZ1

  • Fentanyl IVD, kit, rapid ICT, clinical
Wound Cleanser OTC 2 oz
Pure & Clean, LLC
2.20
In Commercial Distribution

  • 00852421007188 ()

  • Total Volume: 2 Fluid Ounce
1WC2

  • Antimicrobial wound irrigation solution
Wound Cleanser OTC 8 oz
Pure & Clean, LLC
23.07
In Commercial Distribution

  • 00852421007027 ()

  • Total Volume: 8 Fluid Ounce
1WC8

  • Antimicrobial wound irrigation solution
Tubing,Motor,Long,Kavo,OTC
A-DEC, INC.
54.0847.01
In Commercial Distribution

  • 10194665004170 ()
54.0847.01

  • Dental surgical power tool motor, electric
Tubing,Motor,Medium,Kavo,OTC
A-DEC, INC.
54.0846.01
In Commercial Distribution

  • 10194665004156 ()
54.0846.01

  • Dental surgical power tool motor, electric
TopTENS OTC Electrodes (2 x2
COMPASS HEALTH BRANDS CORP.
E1P2020BC2-TT
In Commercial Distribution

  • 80092237616174 ()
  • 30092237616179 ()
  • 00092237616178 ()
  • 01092237616177 ()


  • Transcutaneous electrical stimulation electrode, single-use
OTC hearing aid, behind-the-ear design
Voxx Accessories Corp.
RSH05BK
In Commercial Distribution

  • 00044476153167 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, behind-the-ear design
Voxx Accessories Corp.
RSH053SL
In Commercial Distribution

  • 00044476158056 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, behind-the-ear design
Voxx Accessories Corp.
RSH053BG
In Commercial Distribution

  • 00044476158049 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aid, behind-the-ear design
Voxx Accessories Corp.
RSH05GY
In Commercial Distribution

  • 00044476153150 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aid, behind-the-ear design
Voxx Accessories Corp.
RSH05BG
In Commercial Distribution

  • 00044476153143 ()


  • Air-conduction hearing aid, behind-the-ear
Procellera FLexEFit OTC, 2.5"x6.3"
Vomaris Wound Care, Inc.
2.5"x6.3"
In Commercial Distribution

  • 00810198031140 ()
VFC-2563

  • Bioelectric wound dressing
Procellera Composite OTC; 4' diameter
Vomaris Wound Care, Inc.
4" Diam
In Commercial Distribution

  • 00810198030419 ()
VHC-D04

  • Bioelectric wound dressing
Procellera Composite OTC; 4"x4"
Vomaris Wound Care, Inc.
4"x4"
In Commercial Distribution

  • 00810198030402 ()
VHC-0404

  • Bioelectric wound dressing
Mepore Pro 9x15cm OTC Norden
Mölnlycke Health Care AB
671090
In Commercial Distribution

  • 07323190253050 ()
  • 07323190254040 ()
  • 07323190253043 ()

  • 9cm x 15cm


  • Adhesive bandage
Mepiform OTC 10x18, non sterile
Mölnlycke Health Care AB
293800
In Commercial Distribution

  • 07323190179251 ()
  • 07323190179268 ()
  • 07332430998903 ()

  • 10cm x 18cm


  • Scar-management dressing, single-use
QuickVue At-Home OTC COVID-19 Test
QUIDEL CORPORATION
20402
In Commercial Distribution

  • 30014613339724 ()
20402

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
QuickVue At-Home OTC COVID-19 Test
QUIDEL CORPORATION
20399
In Commercial Distribution

  • 30014613339687 ()
20399

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
QuickVue At-Home OTC COVID-19 Test
QUIDEL CORPORATION
20398
In Commercial Distribution

  • 30014613339670 ()
20398

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
OTC DEVICE TO TREAT WRINKLES
zhongshan Bisen plastic electronic products CO,LTD
900
Not in Commercial Distribution

  • 26928336800386 ()
  • 16928336800389 ()


  • Cosmetic red-light phototherapy system, home-use
OTC DEVICE TO TREAT WRINKLES
zhongshan Bisen plastic electronic products CO,LTD
850
Not in Commercial Distribution

  • 26928336800379 ()
  • 16928336800372 ()


  • Cosmetic red-light phototherapy system, home-use
OTC DEVICE TO TREAT WRINKLES
zhongshan Bisen plastic electronic products CO,LTD
700 BLACK
Not in Commercial Distribution

  • 26928336800362 ()
  • 16928336800365 ()


  • Cosmetic red-light phototherapy system, home-use
OTC DEVICE TO TREAT WRINKLES
zhongshan Bisen plastic electronic products CO,LTD
700 PINK
Not in Commercial Distribution

  • 16928336800358 ()
  • 26928336800355 ()


  • Cosmetic red-light phototherapy system, home-use
Engage Android OTC Rechargeable Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831528 ()
10098

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Rechargeable Grey
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831511 ()
10097

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Black
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831504 ()
10096

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Rechargeable Black
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831498 ()
10095

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Beige
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831429 ()
10080

  • Air-conduction hearing aid, receiver-in-the-ear
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