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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ALLENTOWN LAP CHOLE APP
Cardinal Health 200, LLC
SLC11LLSL1
In Commercial Distribution

  • 50888439303597 ()
  • 10888439303599 ()
SLC11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
ON APP 1.2 ANDROID
Oticon A/S
176635
In Commercial Distribution

  • 05707131328526 ()


  • Hearing aid/implant system remote control
ON APP 1.2 IOS
Oticon A/S
176634
In Commercial Distribution

  • 05707131328519 ()


  • Hearing aid/implant system remote control
OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser
OvuSense 2 App - iOS
VIO HEALTHTECH LIMITED
M032 iOS
In Commercial Distribution

  • 05060508530107 ()


  • Thermometric fertility analyser
Beyond App Android 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control
Beyond App iOS 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689105 ()
5 300 0008 001

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

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex ToneLink App iOS
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702958 ()
5 300 0016 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex MOMENT App iOS
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930313 ()
5 300 0021 001

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

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder
Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001235 ()


  • Electroencephalograph
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001051 ()


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

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software
Osia Smart App (iOS)
COCHLEAR LIMITED
P1340352
In Commercial Distribution

  • 09321502046138 ()
P1340352

  • Audiometric/hearing device software
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