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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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AUDIGY - 00840388200483

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI CROSBICROS RIC 312
In Commercial Distribution

  • 00840388200483 ()


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

MICROTECH - 00840388200476

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI CROSBICROS RIC 312
In Commercial Distribution

  • 00840388200476 ()


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

AUDIGY - 00840388200377

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI 12 RIC 312
In Commercial Distribution

  • 00840388200377 ()


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

MICROTECH - 00840388200360

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI 12 RIC 312
In Commercial Distribution

  • 00840388200360 ()


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

NUEAR - 00840388200353

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI 12 RIC 312
In Commercial Distribution

  • 00840388200353 ()


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

AUDIGY - 00840388200261

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI 16 RIC 312
In Commercial Distribution

  • 00840388200261 ()


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

MICROTECH - 00840388200254

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI 16 RIC 312
In Commercial Distribution

  • 00840388200254 ()


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

NUEAR - 00840388200247

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI 16 RIC 312
In Commercial Distribution

  • 00840388200247 ()


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

AUDIGY - 00840388200155

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI 20 RIC 312
In Commercial Distribution

  • 00840388200155 ()


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

MICROTECH - 00840388200148

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI 20 RIC 312
In Commercial Distribution

  • 00840388200148 ()


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

NUEAR - 00840388200131

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI 20 RIC 312
In Commercial Distribution

  • 00840388200131 ()


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

STARKEY - 00840388200094

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 24 RIC 312 (GS)
In Commercial Distribution

  • 00840388200094 ()


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

AUDIGY - 00840388200032

No Description
Starkey Laboratories, Inc.
AUDIGY AGXS GENESIS AI 24 RIC 312
In Commercial Distribution

  • 00840388200032 ()


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

MICROTECH - 00840388200025

No Description
Starkey Laboratories, Inc.
MICROTECH MT NXG AI 24 RIC 312
In Commercial Distribution

  • 00840388200025 ()


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

NUEAR - 00840388200018

No Description
Starkey Laboratories, Inc.
NUEAR NE NXG AI 24 RIC 312
In Commercial Distribution

  • 00840388200018 ()


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

AUDIBEL - 00842318177506

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA EDGE AI CROSBICROS RIC R
In Commercial Distribution

  • 00842318177506 ()
63199-2

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

AUDIBEL - 00842318177490

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA EDGE AI CROSBICROS RIC 312
In Commercial Distribution

  • 00842318177490 ()
63200-2

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

AUDIBEL - 00842318177483

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA EDGE AI CROSBICROS BTE 13
In Commercial Distribution

  • 00842318177483 ()
63198-2

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

AUDIBEL - 00842318177476

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA EDGE AI 2400 RIC R
In Commercial Distribution

  • 00842318177476 ()
63194-2, 63206-2

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

AUDIBEL - 00842318177469

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA EDGE AI 2400 RIC 312
In Commercial Distribution

  • 00842318177469 ()
63192-2, 63205-2

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

AUDIBEL - 00842318177452

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA EDGE AI 2400 MRIC 312
In Commercial Distribution

  • 00842318177452 ()
63193-2, 63204-2

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

AUDIBEL - 00842318177445

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA EDGE AI 2400 HS R
In Commercial Distribution

  • 00842318177445 ()
63208-ABL

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

AUDIBEL - 00842318177438

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA EDGE AI 2400 BTE R
In Commercial Distribution

  • 00842318177438 ()
63196-2, 63207-2

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

AUDIBEL - 00842318177421

No Description
Starkey Laboratories, Inc.
AUDIBEL VIA EDGE AI 2400 BTE 13
In Commercial Distribution

  • 00842318177421 ()
63195-2, 63203-2

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

aPROMISE - 07350002337028

PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
Exini Diagnostics AB
02
In Commercial Distribution

  • 07350002337028 ()
702

  • Radiology DICOM image processing application software

ATLAS HDSS - 00850011306321

The ATLAS High Density Signal Splitter (HDSS) is an adapter that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiological System (K110967) by Neuralynx, Inc. but also the Quantum Amplifier by Natus Corporation. The ATLAS HDSS shares the buffered outputs from the electrode interface and routes them to both systems to be digitized.
NEURALYNX, INC.
ATLAS HDSS
In Commercial Distribution

  • 00850011306321 ()
31-0602-0031

  • Electrical-only medical device connection cable, reusable

Torana™ - 00860011623915

The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by the users to facilitate custom data workflows that integrate PACS, RIS, databases, and image analysis services. Example usages of Torana™ Medical Imaging Gateway include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server.
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
2.18.2
In Commercial Distribution

  • 00860011623915 ()


  • Radiological PACS software

STARKEY - 00842318199249

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI RIC 312 (GS TIER DEMO)
In Commercial Distribution

  • 00842318199249 ()


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

AUDIBEL - 00842318199157

No Description
Starkey Laboratories, Inc.
AUDIBEL INTRIGUE AI DEMO RIC 312 (TIER DEMO)
In Commercial Distribution

  • 00842318199157 ()


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

STARKEY - 00842318199140

No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI DEMO RIC 312 (TIER DEMO)
In Commercial Distribution

  • 00842318199140 ()


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