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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Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software
t:connect Mobile Application (Android)
Tandem Diabetes Care, Inc.
1004127
In Commercial Distribution

  • 00850006613267 ()


  • Ambulatory insulin infusion pump software, data-display
OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser
Novidan Mobile Application - Android
Novidan, Inc.
99-0011-01
In Commercial Distribution

  • 00850049194471 ()


  • Air-conduction hearing aid, receiver-in-canal
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
DreamMapper Android China Instance
Respironics, Inc.
DreamMapper Android, China Instance - 2
Not in Commercial Distribution

  • 00606959057685 ()
1136947

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047495 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046757 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044357 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Mobile Application Android
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041950 ()
1101479

  • Self-care monitoring/reporting software
iCare PATIENT2 (Android version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851104 ()


  • Medical equipment clinical data interfacing software
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
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