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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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 1.8 ANDROID
Oticon A/S
185788
In Commercial Distribution

  • 05707131335081 ()


  • 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
OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser
PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution

  • 00850677007150 ()
PSM2.2.2

  • Radiological PACS software
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
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
iCare PATIENT2 (Android version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851104 ()


  • Medical equipment clinical data interfacing software
Oticon RemoteCare 3.3.0 Android
Sbo Hearing A/S
228208
In Commercial Distribution

  • 05714464012923 ()


  • Hearing aid/implant system remote control
RemoteLink Connect 3.3.0 Android
Sbo Hearing A/S
228202
In Commercial Distribution

  • 05714464012862 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.5.0 ANDROID
Sbo Hearing A/S
228199
In Commercial Distribution

  • 05714464012831 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.5.0 ANDROID
Sbo Hearing A/S
228197
In Commercial Distribution

  • 05714464012817 ()


  • Hearing aid/implant system remote control
OTICON ON 2.5.0 ANDROID
Sbo Hearing A/S
228192
In Commercial Distribution

  • 05714464012763 ()


  • Hearing aid/implant system remote control
OTICON ON 2.4.0 ANDROID
Sbo Hearing A/S
226658
In Commercial Distribution

  • 05714464012282 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.4.0 ANDROID
Sbo Hearing A/S
226430
In Commercial Distribution

  • 05714464012077 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.4.0 ANDROID
Sbo Hearing A/S
226428
In Commercial Distribution

  • 05714464012053 ()


  • Hearing aid/implant system remote control
OTICON ON 2.3.0 ANDROID
Sbo Hearing A/S
224171
In Commercial Distribution

  • 05714464011629 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.3.0 ANDROID
Sbo Hearing A/S
220592
In Commercial Distribution

  • 05714464011292 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.3.0 ANDROID
Sbo Hearing A/S
220590
In Commercial Distribution

  • 05714464011278 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.1.0 ANDROID
Sbo Hearing A/S
219642
In Commercial Distribution

  • 05714464006441 ()


  • Hearing aid/implant system remote control
REMOTELINK CONNECT 3.1.0 ANDROID
Sbo Hearing A/S
215187
In Commercial Distribution

  • 05714464004638 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.1.0 ANDROID
Sbo Hearing A/S
214716
In Commercial Distribution

  • 05714464003624 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.5.0 ANDROID
Sbo Hearing A/S
274918
In Commercial Distribution

  • 05714464146093 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.5.0 ANDROID
Sbo Hearing A/S
274914
In Commercial Distribution

  • 05714464146055 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.5.0 ANDROID
Sbo Hearing A/S
274912
In Commercial Distribution

  • 05714464146031 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.5.0 ANDROID
Sbo Hearing A/S
274910
In Commercial Distribution

  • 05714464146017 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.4.0 ANDROID
Sbo Hearing A/S
270498
In Commercial Distribution

  • 05714464139521 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.4.0 ANDROID
Sbo Hearing A/S
270496
In Commercial Distribution

  • 05714464139507 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.4.0 ANDROID
Sbo Hearing A/S
270495
In Commercial Distribution

  • 05714464139491 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.4.0 ANDROID
Sbo Hearing A/S
270494
In Commercial Distribution

  • 05714464139484 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.3.0 ANDROID
Sbo Hearing A/S
269355
In Commercial Distribution

  • 05714464133956 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.3.0 ANDROID
Sbo Hearing A/S
269353
In Commercial Distribution

  • 05714464133932 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.3.0 ANDROID
Sbo Hearing A/S
269351
In Commercial Distribution

  • 05714464133918 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.3.0 ANDROID
Sbo Hearing A/S
269347
In Commercial Distribution

  • 05714464133871 ()


  • Hearing aid/implant system remote control
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
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