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 Class Implantable

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Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software
SW M01G02 CARELINK SMARTSYNC ANDROID
MEDTRONIC, INC.
M01G02
In Commercial Distribution

  • 00643169833715 ()


  • Implantable cardiac device management application software
Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674729 ()
5 300 0007 001

  • Tinnitus masking application software
BEYOND app Android version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673579 ()
5 300 0005 001

  • Hearing aid/implant system remote control
APP WIDEX REMOTE CARE ANDROID
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779714 ()
21035228

  • Hearing aid/implant system remote control
BMS CT360 Android Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Android Patient App
Not in Commercial Distribution

  • 00851203006234 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
SONIC SOUNDLINK 3 1.2.0 ANDROID
Sbo Hearing A/S
265709
In Commercial Distribution

  • 05714464127184 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.2.0 ANDROID
Sbo Hearing A/S
265707
In Commercial Distribution

  • 05714464127160 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.1.0 ANDROID
Sbo Hearing A/S
264787
In Commercial Distribution

  • 05714464125210 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.5.0 ANDROID
Sbo Hearing A/S
274916
In Commercial Distribution

  • 05714464146079 ()


  • Hearing aid/implant system remote control
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