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.
GM540TE
In Commercial Distribution

  • 24712832961625 ()
  • 04712832961621 ()
GM540TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM530TE
In Commercial Distribution

  • 24712832961595 ()
  • 04712832961591 ()
GM530TE

  • Analgesic transcutaneous electrical nerve stimulation system
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
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
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
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