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
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 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
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