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

  • 05707131395467 ()


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

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
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
Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution

  • 00850677007150 ()
PSM2.2.2

  • Radiological PACS software
Beyond App Android 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689112 ()
5 300 0009 001

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

  • 05060508530114 ()


  • Thermometric fertility analyser
Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution

  • 00840682147101 ()


  • Ultrasound imaging system application software
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