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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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
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
IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software
Widex ToneLink App iOS
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702958 ()
5 300 0016 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Beyond App iOS 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689105 ()
5 300 0008 001

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

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
REMOTE CARE 1.0 IOS
Oticon A/S
193798
In Commercial Distribution

  • 05707131343932 ()


  • Hearing aid/implant system remote control
OTICON ON 1.8 IOS
Oticon A/S
185783
In Commercial Distribution

  • 05707131335074 ()


  • Hearing aid/implant system remote control
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