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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Smartphone stethoscope software application with AI for iPhones - Rx only
Sparrow Acoustics Inc.
3.x.x
In Commercial Distribution

  • 00860011561729 ()


  • Electronic acoustic stethoscope
LED Lightsource with port light turrent: AI Wf Storz ympus
Avalign Technologies, Inc.
72-983000
In Commercial Distribution

  • 00190776189402 ()


  • Endoscopic light source unit, line-powered
ADAPTERSNAP ON AI TO STORZ ADAPTER AND STRYKER TO STORZ
Avalign Technologies, Inc.
72-5251ACMIST
In Commercial Distribution

  • 00190776209315 ()


  • Luer/non-ISO80369-standardized linear connector, reusable
Liquichek Reticulocyte Control (A-I) Bilevel MiniPak (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
915X
In Commercial Distribution

  • 00847661003793 ()
915X

  • Reticulocyte count IVD, control
Liquichek Reticulocyte Control (A-I) Level 2 (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
917
In Commercial Distribution

  • 00847661003786 ()
917

  • Reticulocyte count IVD, control
Liquichek Reticulocyte Control (A-I) Level 1 (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
916
In Commercial Distribution

  • 00847661003779 ()
916

  • Reticulocyte count IVD, control
Calibration of apolipoprotein A-I and B assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446466
In Commercial Distribution

  • 00842768011535 ()
  • 00842768018602 ()
OUPG09

  • Plasma protein IVD, calibrator
Quantum Pump Frame 2 - Cheltenham
SPECTRUM MEDICAL LIMITED
QPF2
In Commercial Distribution

  • 05060434420756 ()
51-000025-00

  • Cardiopulmonary bypass system roller pump
Quantum Pump Frame 1 - Blackpool
SPECTRUM MEDICAL LIMITED
QPF1
In Commercial Distribution

  • 05060434420749 ()
51-000024-00

  • Extracorporeal blood gas/pH monitor
AUD SHOE QUANTUM ST-GRA COMPL
Gn Hearing A/S
511-004-000-06
In Commercial Distribution

  • 05708296136995 ()


  • Hearing aid/implant system functionality-enhancing device
AUD SHOE QUANTUM GRA COMPL
Gn Hearing A/S
511-004-000-03
In Commercial Distribution

  • 05708296136988 ()


  • Hearing aid/implant system functionality-enhancing device
Quantum E W 13 Dir
Unitron Hearing Ltd
063-5633-01
In Commercial Distribution

  • 00698764455831 ()
063-5633-01

  • Air-conduction hearing aid, in-the-ear
Quantum E W 312 Dir
Unitron Hearing Ltd
063-5632-01
In Commercial Distribution

  • 00698764455824 ()
063-5632-01

  • Air-conduction hearing aid, canal
Quantum E W 312 Omni
Unitron Hearing Ltd
063-5631-01
In Commercial Distribution

  • 00698764455817 ()
063-5631-01

  • Air-conduction hearing aid, canal
Quantum E M Mica Beige
Unitron Hearing Ltd
050-5577-D5
In Commercial Distribution

  • 00698764445436 ()
050-5577-D5

  • Air-conduction hearing aid, behind-the-ear
Quantum E M Silver Mist
Unitron Hearing Ltd
050-5577-68
In Commercial Distribution

  • 00698764445412 ()
050-5577-68

  • Air-conduction hearing aid, behind-the-ear
Quantum E M Light Gray
Unitron Hearing Ltd
050-5577-05
In Commercial Distribution

  • 00698764445399 ()
050-5577-05

  • Air-conduction hearing aid, behind-the-ear
Quantum E S Silver Mist
Unitron Hearing Ltd
050-5576-68
In Commercial Distribution

  • 00698764444712 ()
050-5576-68

  • Air-conduction hearing aid, behind-the-ear
Quantum E S Trans. Blue
Unitron Hearing Ltd
050-5576-37
In Commercial Distribution

  • 00698764444682 ()
050-5576-37

  • Air-conduction hearing aid, behind-the-ear
Quantum E S Trans. Red
Unitron Hearing Ltd
050-5576-36
In Commercial Distribution

  • 00698764444675 ()
050-5576-36

  • Air-conduction hearing aid, behind-the-ear
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