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
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 ITE R
In Commercial Distribution

  • 00842318186638 ()


  • Air-conduction hearing aid, in-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1000 HS R
In Commercial Distribution

  • 00842318186379 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1200 HS R
In Commercial Distribution

  • 00842318186362 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1600 HS R
In Commercial Distribution

  • 00842318186355 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2000 HS R
In Commercial Distribution

  • 00842318186348 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 HS R
In Commercial Distribution

  • 00842318186331 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1000 ITC R
In Commercial Distribution

  • 00842318186072 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1200 ITC R
In Commercial Distribution

  • 00842318186065 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1600 ITC R
In Commercial Distribution

  • 00842318186058 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2000 ITC R
In Commercial Distribution

  • 00842318186041 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 ITC R
In Commercial Distribution

  • 00842318186034 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI CROS RIC 312
In Commercial Distribution

  • 00842318185815 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI CROS RIC R
In Commercial Distribution

  • 00842318185334 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1000 RIC R
In Commercial Distribution

  • 00842318185327 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1200 RIC R
In Commercial Distribution

  • 00842318185310 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1600 RIC R
In Commercial Distribution

  • 00842318185303 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2000 RIC R
In Commercial Distribution

  • 00842318185297 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 RIC R
In Commercial Distribution

  • 00842318185280 ()


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

  • 00842318184573 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1000 BTE 13
In Commercial Distribution

  • 00842318184566 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1200 BTE 13
In Commercial Distribution

  • 00842318184559 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 1600 BTE 13
In Commercial Distribution

  • 00842318184542 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2000 BTE 13
In Commercial Distribution

  • 00842318184535 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 BTE 13
In Commercial Distribution

  • 00842318184528 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
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
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
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
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO T.5 AI BTE 13
In Commercial Distribution

  • 00842318179135 ()
63113-E

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 9.5 AI RIC R (Right)
In Commercial Distribution

  • 00842318179128 ()
63040-E

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 9.5 AI MRIC 312 (Right)
In Commercial Distribution

  • 00842318179111 ()
63046-E

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 3.5 AI RIC R (Right)
In Commercial Distribution

  • 00842318179098 ()
63042-E

  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 3.5 AI MRIC 312 (Right)
In Commercial Distribution

  • 00842318179081 ()
63048-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 2.5 AI RIC R (Right)
In Commercial Distribution

  • 00842318179050 ()
63043-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 2.5 AI RIC 312 (Right)
In Commercial Distribution

  • 00842318179043 ()
63084-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 11.6 AI RIC R (Left)
In Commercial Distribution

  • 00842318179012 ()
63194-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO 11.6 AI MRIC 312 (Right)
In Commercial Distribution

  • 00842318179005 ()
63193-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 24 RIC RT (SCIF GS)
In Commercial Distribution

  • 00840388201459 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 24 RIC RT (SCIF GS)
In Commercial Distribution

  • 00840388201442 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Audigy AGXs G Series AI 10 RIC R
In Commercial Distribution

  • 00840388209844 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Audigy AGXs G Series AI 12 RIC R
In Commercial Distribution

  • 00840388209769 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Audigy AGXs G Series AI 16 RIC R
In Commercial Distribution

  • 00840388209707 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
Audigy AGXs G Series AI 16 RIC 312
In Commercial Distribution

  • 00840388209370 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Audigy AGXs G Series AI 16 RIC 312
In Commercial Distribution

  • 00840388209363 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Audigy AGXs G Series AI 12 RIC 312
In Commercial Distribution

  • 00840388209356 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
Audigy AGXs G Series AI 10 RIC 312
In Commercial Distribution

  • 00840388209349 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
AUDIOSYNC EDGE AI 24 RIC RT (TIER DEMO)
In Commercial Distribution

  • 00840388206171 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
NUEAR EDGE AI 24 RIC RT (TIER DEMO)
In Commercial Distribution

  • 00840388206157 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
STARKEY EDGE AI 24 RIC RT (TIER DEMO)
In Commercial Distribution

  • 00840388206126 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
GOVT EDGE AI 24 RIC RT (VA DEMO)
In Commercial Distribution

  • 00840388206119 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 24 RIC RT (DEMO)
In Commercial Distribution

  • 00840388206096 ()


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