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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SOUNDLINK 3 1.5.0 IOS
Sbo Hearing A/S
274915
In Commercial Distribution

  • 05714464146062 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.5.0 IOS
Sbo Hearing A/S
274913
In Commercial Distribution

  • 05714464146048 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.5.0 IOS
Sbo Hearing A/S
274911
In Commercial Distribution

  • 05714464146024 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.4.0 IOS
Sbo Hearing A/S
270493
In Commercial Distribution

  • 05714464139477 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.4.0 IOS
Sbo Hearing A/S
270491
In Commercial Distribution

  • 05714464139453 ()


  • Hearing aid/implant system remote control
Cara i500 ios System
Kulzer GmbH
66081716
In Commercial Distribution

  • J014660817160 ()
66081716

  • Dental milling system, CAD/CAM, laboratory
Cara i500 ios scanner
Kulzer GmbH
66077970
In Commercial Distribution

  • J014660779700 ()
66077970

  • Dental milling system, CAD/CAM, laboratory
OvuSense 2 App - iOS
VIO HEALTHTECH LIMITED
M032 iOS
In Commercial Distribution

  • 05060508530107 ()


  • Thermometric fertility analyser
Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
Novidan Mobile Application - iOS
Novidan, Inc.
99-0011-02
In Commercial Distribution

  • 00850049194464 ()


  • Air-conduction hearing aid, receiver-in-canal
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