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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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Sonic - 05714464058969

SoundLink 3 1.0.0 Android
Sbo Hearing A/S
242485
In Commercial Distribution

  • 05714464058969 ()


  • Hearing aid/implant system remote control

Oticon - 05714464060320

OTICON REMOTECARE 3.5.0 ANDROID
Sbo Hearing A/S
247222
In Commercial Distribution

  • 05714464060320 ()


  • Hearing aid/implant system remote control

Neutral - 05714464058945

RemoteLink 2 1.0.0 Android
Sbo Hearing A/S
242483
In Commercial Distribution

  • 05714464058945 ()


  • Hearing aid/implant system remote control

Oticon - 05714464146093

OTICON COMPANION 1.5.0 ANDROID
Sbo Hearing A/S
274918
In Commercial Distribution

  • 05714464146093 ()


  • Hearing aid/implant system remote control

Sonic - 05714464146055

SOUNDLINK 3 1.5.0 ANDROID
Sbo Hearing A/S
274914
In Commercial Distribution

  • 05714464146055 ()


  • Hearing aid/implant system remote control

Neutral - 05714464146031

REMOTELINK 2 1.5.0 ANDROID
Sbo Hearing A/S
274912
In Commercial Distribution

  • 05714464146031 ()


  • Hearing aid/implant system remote control

Oticon - 05714464139521

OTICON COMPANION 1.4.0 ANDROID
Sbo Hearing A/S
270498
In Commercial Distribution

  • 05714464139521 ()


  • Hearing aid/implant system remote control

Sonic - 05714464139507

SOUNDLINK 3 1.4.0 ANDROID
Sbo Hearing A/S
270496
In Commercial Distribution

  • 05714464139507 ()


  • Hearing aid/implant system remote control

Neutral - 05714464139491

REMOTELINK 2 1.4.0 ANDROID
Sbo Hearing A/S
270495
In Commercial Distribution

  • 05714464139491 ()


  • Hearing aid/implant system remote control

Sonic - 05714464133956

SOUNDLINK 3 1.3.0 ANDROID
Sbo Hearing A/S
269355
In Commercial Distribution

  • 05714464133956 ()


  • Hearing aid/implant system remote control

Neutral - 05714464133932

REMOTELINK 2 1.3.0 ANDROID
Sbo Hearing A/S
269353
In Commercial Distribution

  • 05714464133932 ()


  • Hearing aid/implant system remote control

Oticon - 05714464133871

OTICON COMPANION 1.3.0 ANDROID
Sbo Hearing A/S
269347
In Commercial Distribution

  • 05714464133871 ()


  • Hearing aid/implant system remote control

Neutral - 05714464127207

REMOTELINK 2 1.2.0 ANDROID
Sbo Hearing A/S
265711
In Commercial Distribution

  • 05714464127207 ()


  • Hearing aid/implant system remote control

Oticon - 05714464127146

OTICON COMPANION 1.2.0 ANDROID
Sbo Hearing A/S
265703
In Commercial Distribution

  • 05714464127146 ()


  • Hearing aid/implant system remote control

Neutral - 05714464125173

REMOTELINK 2 1.1.0 ANDROID
Sbo Hearing A/S
264783
In Commercial Distribution

  • 05714464125173 ()


  • Hearing aid/implant system remote control

Oticon - 05714464125234

OTICON COMPANION 1.1.0 ANDROID
Sbo Hearing A/S
264789
In Commercial Distribution

  • 05714464125234 ()


  • Hearing aid/implant system remote control

Sonic - 05714464125197

SOUNDLINK 3 1.1.0 ANDROID
Sbo Hearing A/S
264785
In Commercial Distribution

  • 05714464125197 ()


  • Hearing aid/implant system remote control

Neutral - 05714464168088

REMOTELINK 2 1.6.0 ANDROID
Sbo Hearing A/S
285025
In Commercial Distribution

  • 05714464168088 ()


  • Hearing aid wireless-fitting computer-aided set

Oticon - 05714464168026

OTICON COMPANION 1.6.0 ANDROID
Sbo Hearing A/S
285019
In Commercial Distribution

  • 05714464168026 ()


  • Hearing aid wireless-fitting computer-aided set

Lucid Audio - 00846430005853

TALA Android EARPIECE RIGHT
ETYMOTIC RESEARCH, INC.
TALA ANDROID EARP R
In Commercial Distribution

  • 00846430005853 ()


  • Air-conduction hearing aid, in-the-ear

Lucid Audio - 00846430005846

TALA Android EARPIECE LEFT
ETYMOTIC RESEARCH, INC.
TALA ANDROID EARP L
In Commercial Distribution

  • 00846430005846 ()


  • Air-conduction hearing aid, in-the-ear

FreeStyle LibreLink - 00357599000042

FreeStyle LibreLink Android US
ABBOTT DIABETES CARE INC
71732-01
In Commercial Distribution

  • 00357599000042 ()
71732-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

DreamMapper - 00606959057685

DreamMapper Android China Instance
Respironics, Inc.
DreamMapper Android, China Instance - 2
Not in Commercial Distribution

  • 00606959057685 ()
1136947

  • Self-care monitoring/reporting software

Vscan - 00840682147101

Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution

  • 00840682147101 ()


  • Ultrasound imaging system application software

BioStamp nPoint™ - G012SW0026

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

BioStamp nPoint™ - G012SW0025

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

BioStamp nPoint™ - G012SW0027

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

PACS Scan Mobile - 00850677007150

PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution

  • 00850677007150 ()
PSM2.2.2

  • Radiological PACS software

Oticon - 05707131395467

OTICON ON 2.1.0 ANDROID
Oticon A/S
219644
In Commercial Distribution

  • 05707131395467 ()


  • Hearing aid/implant system remote control

Oticon - 05707131357618

OTICON ON 2.0 ANDROID
Oticon A/S
204455
In Commercial Distribution

  • 05707131357618 ()


  • Hearing aid/implant system remote control

Oticon - 05707131357595

OTICON REMOTECARE 3.0 ANDROID
Oticon A/S
204453
In Commercial Distribution

  • 05707131357595 ()


  • Hearing aid/implant system remote control

Oticon - 05707131337368

OTICON ON 1.9 ANDROID
Bernafon AG
189259
In Commercial Distribution

  • 05707131337368 ()


  • Hearing aid/implant system remote control

Oticon - 05707131335081

OTICON ON 1.8 ANDROID
Oticon A/S
185788
In Commercial Distribution

  • 05707131335081 ()


  • Hearing aid/implant system remote control

Oticon - 05707131329998

OTICON ON 1.4 ANDROID
Oticon A/S
178498
In Commercial Distribution

  • 05707131329998 ()


  • Hearing aid/implant system remote control

Oticon - 05707131349217

OTICON ON 1.10 ANDROID
Oticon A/S
199519
In Commercial Distribution

  • 05707131349217 ()


  • Hearing aid/implant system remote control

Novidan - 00850049194471

Novidan Mobile Application - Android
Novidan, Inc.
99-0011-01
In Commercial Distribution

  • 00850049194471 ()


  • Air-conduction hearing aid, receiver-in-canal

t:connect Mobile Application (Android) - 00850006613267

t:connect Mobile Application (Android)
Tandem Diabetes Care, Inc.
1004127
In Commercial Distribution

  • 00850006613267 ()


  • Ambulatory insulin infusion pump software, data-display

Oticon - 05714464042456

Oticon RemoteCare 3.4.0 Android
Sbo Hearing A/S
236787
In Commercial Distribution

  • 05714464042456 ()


  • Hearing aid/implant system remote control

Neutral - 05714464034666

RemoteLink Connect 3.4.0 Android
Sbo Hearing A/S
234033
In Commercial Distribution

  • 05714464034666 ()


  • Hearing aid/implant system remote control

Oticon - 05714464012923

Oticon RemoteCare 3.3.0 Android
Sbo Hearing A/S
228208
In Commercial Distribution

  • 05714464012923 ()


  • Hearing aid/implant system remote control
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