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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OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM520TE
In Commercial Distribution

  • 24712832961564 ()
  • 04712832961560 ()
GM520TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM511TE
In Commercial Distribution

  • 24712832961533 ()
  • 04712832961539 ()
GM511TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM510TE
In Commercial Distribution

  • 24712832961502 ()
  • 04712832961508 ()
GM510TE

  • Analgesic transcutaneous electrical nerve stimulation system
Control Module,Kavo,OTC
A-DEC, INC.
54.0809.01
In Commercial Distribution

  • 10194665005450 ()
54.0809.01

  • Remotely-driven surgical/dental system drive cable
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321308 ()
  • 00850065321301 ()
CE-A90A(White)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321292 ()
  • 00850065321295 ()
CE-A90A(Black)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321261 ()
  • 00850065321264 ()
CE-A90A(skin)

  • Air-conduction hearing aid, in-the-ear
Wound & Skin Hydrogel OTC
Seriously Clean, Ltd.
221Z1
In Commercial Distribution

  • 00851608007539 ()


  • Antimicrobial wound irrigation solution
OTC Rechargeable Hearing Aid
Audicon Corporation
Torch
In Commercial Distribution

  • 10860010331078 ()
  • 00860010331071 ()


  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Solid
In Commercial Distribution

  • 10860010331061 ()
  • 00860010331064 ()


  • Air-conduction hearing aid, behind-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Style
In Commercial Distribution

  • 00860010331057 ()
  • 10860010331054 ()


  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Fusion
In Commercial Distribution

  • 00860010331026 ()
  • 10860010331023 ()
  • 20860010331020 ()
  • 40860010331024 ()


  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Essential
In Commercial Distribution

  • 10860010331009 ()
  • 00860010331002 ()
CE-A39HT(White)

  • Air-conduction hearing aid, in-the-ear
1T,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H A2553
In Commercial Distribution

  • 06936983149310 ()
USFTY1AT-1

  • Fentanyl IVD, kit, rapid ICT, clinical
OTC Primer 1.5ml Bottle
PARKELL, INC.
S826
Not in Commercial Distribution

  • M595S8260 ()
S826

  • Denture reliner, soft, professional
Finger Pulse Oximeter, OTC
COMPASS HEALTH BRANDS CORP.
50052
Not in Commercial Distribution

  • 80092237604591 ()
  • 00092237604595 ()


  • Pulse oximeter probe, reusable
Finger Pulse Oximeter, OTC
COMPASS HEALTH BRANDS CORP.
50052
Not in Commercial Distribution

  • 00092237604595 ()
  • 30815067013372 ()
  • 00815067013371 ()


  • Pulse oximeter probe, reusable
STERILE OTC BASIC PACK
Cardinal Health 200, LLC
SBA5CBPGSB
In Commercial Distribution

  • 50887488789840 ()
  • 10887488789842 ()
SBA5CBPGSB

  • General surgical procedure kit, non-medicated, single-use
Engage Android OTC Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831481 ()
10094

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

  • 00810068831474 ()
10093

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

  • 00810068831467 ()
10092

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

  • 00810068831450 ()
10091

  • Air-conduction hearing aid, receiver-in-the-ear
Enrich Pro BTE OTC
HEARING LAB TECHNOLOGY, LLC
Enrich Pro BTE
In Commercial Distribution

  • 00810068831443 ()
10082

  • Air-conduction hearing aid acoustic tube
Engage Android OTC Beige
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831399 ()
10077

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

  • 00810068831382 ()
10076

  • Air-conduction hearing aid, receiver-in-the-ear
Lucid® FIO OTC
HEARING LAB TECHNOLOGY, LLC
7287
In Commercial Distribution

  • 00810068830446 ()
HLT-FIO

  • Air-conduction hearing aid, canal
Mepore 9x15cm OTC Norden
Mölnlycke Health Care AB
671000
In Commercial Distribution

  • 07323190254385 ()
  • 07323190254842 ()
  • 07323190254378 ()

  • 9cm x 15cm


  • Adhesive bandage
Cavitron® Steri-Mate® Handpiece Sterile Lavage Adapter
Dentsply Professional
81345
Not in Commercial Distribution

  • D003813451 ()


  • Oral lavage system
Cavitron® Steri-Mate® Handpiece Sterile Lavage Kit. Contains: Infuser Bag, and Adapter.
Dentsply Professional
81340
Not in Commercial Distribution

  • D003813401 ()


  • Oral lavage system
Jacoti Hearing Center 1.X
Jacoti
Jacoti Hearing Center 1.X
In Commercial Distribution

  • 05407004250021 ()


  • Self-testing tone audiometer
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