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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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Dexcom Follow App for Android - 00386270001917

US Dexcom Follow App for Android (mg/dL), v4
Dexcom, Inc.
SW10583
In Commercial Distribution

  • 00386270001917 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Axon - 09413000078510

Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system

Clue App - 04260749840046

Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840046 ()


  • Self-care monitoring/reporting software

Clue Conceive - 04260749840022

Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840022 ()


  • Self-care monitoring/reporting software

Bernafon - 05711583029917

EASYCONTROL-A 1.4 ANDROID
Bernafon AG
178501
In Commercial Distribution

  • 05711583029917 ()


  • Hearing aid/implant system remote control

Bernafon - 05711584095508

EASYCONTROL-A 1.10 ANDROID
Bernafon AG
199522
In Commercial Distribution

  • 05711584095508 ()


  • Hearing aid/implant system remote control

Bernafon - 05711584085349

EASYCONTROL-A 1.9 ANDROID
Oticon A/S
189255
In Commercial Distribution

  • 05711584085349 ()


  • Hearing aid/implant system remote control

Oticon - 05707131328540

REMOTELINK 1.2 ANDROID
Oticon A/S
176637
In Commercial Distribution

  • 05707131328540 ()


  • Hearing aid/implant system remote control

HearCare MED-EL - 09008737431716

Mobile application (Android)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
43171
In Commercial Distribution

  • 09008737431716 ()


  • Audiometric/hearing device software

AudioKey 3 - 09008737413422

Mobile application (Android)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
41342
In Commercial Distribution

  • 09008737413422 ()


  • Audiometric/hearing device software
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