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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ON APP 1.2 IOS
Oticon A/S
176634
In Commercial Distribution

  • 05707131328519 ()


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

  • 05060508530107 ()


  • Thermometric fertility analyser
SCALER/HOE U15/TG
Power Dental U.S.A. Inc.
1707
In Commercial Distribution

  • D94317070 ()
1707

  • Dental excavator, reusable
  • Manual dental scaler, reusable
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 iOS
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702958 ()
5 300 0016 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 iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
Osia Smart App (iOS)
COCHLEAR LIMITED
P1340352
In Commercial Distribution

  • 09321502046138 ()
P1340352

  • Audiometric/hearing device software
Nucleus Smart App, (iOS)
COCHLEAR LIMITED
P832154
In Commercial Distribution

  • 09321502036788 ()
P832154

  • Audiometric/hearing device software
t:connect Mobile Application (iOS)
Tandem Diabetes Care, Inc.
1004128
In Commercial Distribution

  • 00850006613274 ()


  • Ambulatory insulin infusion pump software, data-display
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