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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Beyond App iOS 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689105 ()
5 300 0008 001

  • Hearing aid/implant system remote control
Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
Novidan Mobile Application - iOS
Novidan, Inc.
99-0011-02
In Commercial Distribution

  • 00850049194464 ()


  • Air-conduction hearing aid, receiver-in-canal
SOUNDLINK 2 1.9 IOS
Sonic Innovations, Inc.
189262
In Commercial Distribution

  • 05711583031880 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.8 IOS
Sonic Innovations, Inc.
185787
In Commercial Distribution

  • 05711583030142 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.1.0 IOS
Sonic Innovations, Inc.
214710
In Commercial Distribution

  • 05711583038216 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.0 IOS
Sonic Innovations, Inc.
204547
In Commercial Distribution

  • 05711583037455 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.10 IOS
Sonic Innovations, Inc.
199525
In Commercial Distribution

  • 05711583037417 ()


  • Hearing aid/implant system remote control
Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software
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