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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12mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-12
Not in Commercial Distribution

  • 00846468047856 ()
83-RASP-12

  • Bone file/rasp, manual, reusable
8mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-08
Not in Commercial Distribution

  • 00846468047795 ()
83-DILATOR-08

  • Nerve/vessel retractor
5mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-05
Not in Commercial Distribution

  • 00846468047788 ()
83-DILATOR-05

  • Nerve/vessel retractor
Barrel Plate Inserter
Pioneer Surgical Technology, Inc.
83-B-INSERTER
Not in Commercial Distribution

  • 00846468047757 ()
83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit
No Description
SPECTRUM MEDICAL SRL
VT75-C2U
In Commercial Distribution

  • 18051160301857 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
CGSP8-B1
In Commercial Distribution

  • 18051160303097 ()


  • Cardioplegia solution administration kit
No Description
SPECTRUM MEDICAL SRL
CGSP8-B0
In Commercial Distribution

  • 18051160302809 ()


  • Cardioplegia solution administration kit
No Description
Starkey Laboratories, Inc.
EVOLV AI IIC NW
In Commercial Distribution

  • 00842318189837 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
EVOLV AI HS R
In Commercial Distribution

  • 00842318189721 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
EVOLV AI ITE R
In Commercial Distribution

  • 00842318189714 ()


  • Air-conduction hearing aid, in-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
EVOLV AI ITC R
In Commercial Distribution

  • 00842318189707 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
Fractional RF Quantum Handpiece which comprises canula with active electrodes, handle, cable and connector Handpiece HP2539B6A has a canula of 3.3mm diameter and 25cm long. Maximal RF power is 60W.
INMODE M.D LTD
HP2539B6A
In Commercial Distribution

  • 07290019863076 ()
HP2539B6A

  • Radio-frequency fat liquefaction system
Fractional RF Quantum Handpiece which comprises canula with active electrodes, handle, cable and connector Handpiece HP1022B6A has a canula diameter of 2mm and 10cm long. Maximal RF power is 35W.
INMODE M.D LTD
HP1022B6A
In Commercial Distribution

  • 07290019863069 ()
HP1022B6A

  • Radio-frequency fat liquefaction system
No Description
SPECTRUM MEDICAL SRL
HX22W-C1
In Commercial Distribution

  • 08051160301232 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-C0
In Commercial Distribution

  • 08051160301225 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX32W-C0
In Commercial Distribution

  • 08051160301218 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX11W-S1
In Commercial Distribution

  • 08051160301201 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX11W-S0
In Commercial Distribution

  • 08051160301195 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-S0
In Commercial Distribution

  • 08051160301188 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX55W-S0
In Commercial Distribution

  • 08051160301171 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-S1
In Commercial Distribution

  • 08051160301003 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
CP20V-VT
In Commercial Distribution

  • 08051160300846 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP22V-VT
In Commercial Distribution

  • 08051160300624 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP22V-NG
In Commercial Distribution

  • 18051160302991 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP37V-VT
In Commercial Distribution

  • 18051160302663 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
HX11W-S2
In Commercial Distribution

  • 18051160302151 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
VT160-C1U
In Commercial Distribution

  • 08051160301447 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
VT200-C1U
In Commercial Distribution

  • 08051160301423 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
HX22W-C5
In Commercial Distribution

  • 08051160301263 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX22W-C4
In Commercial Distribution

  • 08051160301256 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX32W-C4
In Commercial Distribution

  • 08051160301249 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX32V-C0W
In Commercial Distribution

  • 18051160302267 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX55V-S0W
In Commercial Distribution

  • 18051160302205 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX11W-S2M
In Commercial Distribution

  • 18051160302175 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX11W-S1M
In Commercial Distribution

  • 18051160302168 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
VT75-C1U
In Commercial Distribution

  • 18051160301840 ()


  • Extracorporeal membrane oxygenator
No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI MRIC 312
In Commercial Distribution

  • 00842318171856 ()
63045-0

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI RIC R
In Commercial Distribution

  • 00842318171443 ()
63039-0

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI RIC 312
In Commercial Distribution

  • 00842318148322 ()
64372-0

  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI BTE 13
In Commercial Distribution

  • 00842318147462 ()
64493-0

  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI HS R
In Commercial Distribution

  • 00842318198051 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
INTRIGUE AI 12 ITE R
In Commercial Distribution

  • 00842318196699 ()


  • Air-conduction hearing aid, in-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
INTRIGUE AI 16 ITE R
In Commercial Distribution

  • 00842318196682 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, in-the-ear
No Description
Starkey Laboratories, Inc.
INTRIGUE AI 20 ITE R
In Commercial Distribution

  • 00842318196675 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, in-the-ear
No Description
Starkey Laboratories, Inc.
INTRIGUE AI 24 ITE R
In Commercial Distribution

  • 00842318196668 ()


  • Air-conduction hearing aid, in-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI BTE R
In Commercial Distribution

  • 00842318190628 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI RIC R
In Commercial Distribution

  • 00842318190611 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI MRIC 312
In Commercial Distribution

  • 00842318190604 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI BTE 13
In Commercial Distribution

  • 00842318190598 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
STARKEY EVOLV AI RIC 312
In Commercial Distribution

  • 00842318190581 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
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