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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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
Investigator application for Android
Medidata Solutions, Inc.
SW-0027
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Sync application for Android
Medidata Solutions, Inc.
SW-0026
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link application for Android
Medidata Solutions, Inc.
SW-0025
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Patient application for Android
MC10, INC.
SW-0042
Not in Commercial Distribution

  • B493SW0042 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
Investigator application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0027 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Sync application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0026 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link application for Android
MC10, INC.
SW-0025
Not in Commercial Distribution

  • B493SW0025 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
Libre Android App US
ABBOTT DIABETES CARE INC
78745-01
In Commercial Distribution

  • 00357599840006 ()
78745-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle LibreLink Android US
ABBOTT DIABETES CARE INC
71732-01
In Commercial Distribution

  • 00357599000042 ()
71732-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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