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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BERNAFON APP 1.2.0 ANDROID
Sbo Hearing A/S
265713
In Commercial Distribution

  • 05714464127221 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.2.0 ANDROID
Sbo Hearing A/S
265711
In Commercial Distribution

  • 05714464127207 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.2.0 ANDROID
Sbo Hearing A/S
265703
In Commercial Distribution

  • 05714464127146 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.1.0 ANDROID
Sbo Hearing A/S
264789
In Commercial Distribution

  • 05714464125234 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.1.0 ANDROID
Sbo Hearing A/S
264785
In Commercial Distribution

  • 05714464125197 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.1.0 ANDROID
Sbo Hearing A/S
264783
In Commercial Distribution

  • 05714464125173 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.1.0 ANDROID
Sbo Hearing A/S
264781
In Commercial Distribution

  • 05714464125159 ()


  • Hearing aid/implant system remote control
OTICON ON 2.1.0 ANDROID
Oticon A/S
219644
In Commercial Distribution

  • 05707131395467 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.1.0 ANDROID
Sonic Innovations, Inc.
214711
In Commercial Distribution

  • 05711583038223 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.0 ANDROID
Sonic Innovations, Inc.
204548
In Commercial Distribution

  • 05711583037462 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.10 ANDROID
Sonic Innovations, Inc.
199524
In Commercial Distribution

  • 05711583037400 ()


  • Hearing aid enhanced audio device, telecommunication/multimedia
SOUNDLINK 2 1.9 ANDROID
Sonic Innovations, Inc.
189263
In Commercial Distribution

  • 05711583031897 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.8 ANDROID
Sonic Innovations, Inc.
185793
In Commercial Distribution

  • 05711583030159 ()


  • Hearing aid/implant system remote control
Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

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

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control
Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution

  • 00850677007150 ()
PSM2.2.2

  • Radiological PACS software
OTICON ON 1.8 ANDROID
Oticon A/S
185788
In Commercial Distribution

  • 05707131335081 ()


  • Hearing aid/implant system remote control
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006432 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006364 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Android App
Not in Commercial Distribution

  • 00851203006128 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Patient Android App
Not in Commercial Distribution

  • 00851203006111 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Consumer Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer Android App
Not in Commercial Distribution

  • 00851203006036 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
OTICON ON 2.0 ANDROID
Oticon A/S
204455
In Commercial Distribution

  • 05707131357618 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.0 ANDROID
Oticon A/S
204453
In Commercial Distribution

  • 05707131357595 ()


  • Hearing aid/implant system remote control
OTICON ON 1.10 ANDROID
Oticon A/S
199519
In Commercial Distribution

  • 05707131349217 ()


  • Hearing aid/implant system remote control
OTICON ON 1.9 ANDROID
Bernafon AG
189259
In Commercial Distribution

  • 05707131337368 ()


  • Hearing aid/implant system remote control
OTICON ON 1.4 ANDROID
Oticon A/S
178498
In Commercial Distribution

  • 05707131329998 ()


  • Hearing aid/implant system remote control
ON APP 1.2 ANDROID
Oticon A/S
176635
In Commercial Distribution

  • 05707131328526 ()


  • Hearing aid/implant system remote control
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