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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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Starkey Laboratories, Inc.
AUDIGY AGXS EVOLV AI 2400 POWER PLUS BTE 13
In Commercial Distribution

  • 00842318187581 ()


  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO T.6 AI RIC R (Right)
In Commercial Distribution

  • 00842318179159 ()
63199-E

  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
PRO AKUSTIK IPRO T.5 AI RIC R (Right)
In Commercial Distribution

  • 00842318179142 ()
63105-E

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

  • 00840388206089 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
AUDIGY AGXS EDGE AI 24 RIC 312 (TIER DEMO)
In Commercial Distribution

  • 00840388204184 ()


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

  • 00840388203682 ()


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

  • 00840388203620 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, receiver-in-canal
No Description
Starkey Laboratories, Inc.
STARKEY GENESIS AI 24 MRIC R (GS) (VA TIER DEMO)
In Commercial Distribution

  • 00842318198853 ()


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

  • 00840388201466 ()


  • Air-conduction hearing aid, receiver-in-canal
  • Tinnitus masking application software
The “Tyto Insights for Wheeze Detection” is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics. It automatically analyses the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.
TYTO CARE LTD
Tyto Insights for Wheeze Detection _US
In Commercial Distribution

  • 07290016672886 ()


  • Electronic acoustic stethoscope
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