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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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Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 - PL - 08051160301249

No Description
SPECTRUM MEDICAL SRL
HX32W-C4
In Commercial Distribution

  • 08051160301249 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 W - 18051160302267

No Description
SPECTRUM MEDICAL SRL
HX32V-C0W
In Commercial Distribution

  • 18051160302267 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W - 18051160302205

No Description
SPECTRUM MEDICAL SRL
HX55V-S0W
In Commercial Distribution

  • 18051160302205 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 M - 18051160302175

No Description
SPECTRUM MEDICAL SRL
HX11W-S2M
In Commercial Distribution

  • 18051160302175 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 M - 18051160302168

No Description
SPECTRUM MEDICAL SRL
HX11W-S1M
In Commercial Distribution

  • 18051160302168 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U - 18051160301840

No Description
SPECTRUM MEDICAL SRL
VT75-C1U
In Commercial Distribution

  • 18051160301840 ()


  • Extracorporeal membrane oxygenator

STARKEY - 00842318179302

No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI RIC R
In Commercial Distribution

  • 00842318179302 ()


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

STARKEY - 00842318179296

No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI RIC 312
In Commercial Distribution

  • 00842318179296 ()


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

STARKEY - 00842318179272

No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI BTE R
In Commercial Distribution

  • 00842318179272 ()
63122P1

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear

NUEAR - 00842318178862

No Description
Starkey Laboratories, Inc.
NUEAR CIRCA AI RIC R
In Commercial Distribution

  • 00842318178862 ()


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

NUEAR - 00842318178855

No Description
Starkey Laboratories, Inc.
NUEAR CIRCA AI RIC 312
In Commercial Distribution

  • 00842318178855 ()


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

NUEAR - 00842318178831

No Description
Starkey Laboratories, Inc.
NUEAR CIRCA AI BTE R
In Commercial Distribution

  • 00842318178831 ()
63122P4

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software

MICROTECH - 00842318178480

No Description
Starkey Laboratories, Inc.
MICROTECH ESENTIA AI BTE R
In Commercial Distribution

  • 00842318178480 ()
63122P8

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear

AUDIBEL - 00842318177384

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA AI BTE R
In Commercial Distribution

  • 00842318177384 ()
63122P2

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear

STARKEY - 00842318171856

No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI MRIC 312
In Commercial Distribution

  • 00842318171856 ()
63045-0

  • Air-conduction hearing aid, receiver-in-canal

STARKEY - 00842318171443

No Description
Starkey Laboratories, Inc.
STARKEY LIVIO AI RIC R
In Commercial Distribution

  • 00842318171443 ()
63039-0

  • Air-conduction hearing aid, receiver-in-canal

AUDIBEL - 00840388201244

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI RIC 312
In Commercial Distribution

  • 00840388201244 ()


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

STARKEY - 00840388201237

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI RIC 312
In Commercial Distribution

  • 00840388201237 ()


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

AUDIBEL - 00840388201206

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI MRIC R
In Commercial Distribution

  • 00840388201206 ()


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

STARKEY - 00840388201190

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI MRIC R
In Commercial Distribution

  • 00840388201190 ()


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

AUDIBEL - 00840388201169

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI RIC RT
In Commercial Distribution

  • 00840388201169 ()


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

STARKEY - 00840388201152

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI RIC RT
In Commercial Distribution

  • 00840388201152 ()


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

STARKEY - 00840388204849

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 12 CIC
In Commercial Distribution

  • 00840388204849 ()


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

NUEAR - 00840388204832

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 12 CIC
In Commercial Distribution

  • 00840388204832 ()


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

AUDIOSYNC - 00840388204788

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 12 CIC
In Commercial Distribution

  • 00840388204788 ()


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

AUDIBEL - 00840388204764

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 12 CIC
In Commercial Distribution

  • 00840388204764 ()


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

STARKEY - 00840388204740

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 16 CIC
In Commercial Distribution

  • 00840388204740 ()


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

NUEAR - 00840388204726

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 16 CIC
In Commercial Distribution

  • 00840388204726 ()


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

AUDIOSYNC - 00840388204672

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 16 CIC
In Commercial Distribution

  • 00840388204672 ()


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

AUDIBEL - 00840388204658

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 16 CIC
In Commercial Distribution

  • 00840388204658 ()


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

STARKEY - 00840388204641

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 20 CIC
In Commercial Distribution

  • 00840388204641 ()


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

NUEAR - 00840388204634

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 20 CIC
In Commercial Distribution

  • 00840388204634 ()


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

AUDIOSYNC - 00840388204580

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 20 CIC
In Commercial Distribution

  • 00840388204580 ()


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

AUDIBEL - 00840388204566

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 20 CIC
In Commercial Distribution

  • 00840388204566 ()


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

NUEAR - 00840388204559

No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 24 CIC
In Commercial Distribution

  • 00840388204559 ()


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

STARKEY - 00840388204528

No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 CIC
In Commercial Distribution

  • 00840388204528 ()


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

AUDIOSYNC - 00840388204498

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 24 CIC
In Commercial Distribution

  • 00840388204498 ()


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

AUDIBEL - 00840388204474

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI 24 CIC
In Commercial Distribution

  • 00840388204474 ()


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

AUDIOSYNC - 00840388204412

No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI RIC 312
In Commercial Distribution

  • 00840388204412 ()


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

AUDIBEL - 00840388204399

No Description
Starkey Laboratories, Inc.
AUDIBEL VITALITY AI RIC 312
In Commercial Distribution

  • 00840388204399 ()


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