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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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
t:connect Mobile Application (iOS)
Tandem Diabetes Care, Inc.
1004128
In Commercial Distribution

  • 00850006613274 ()


  • Ambulatory insulin infusion pump software, data-display
SOUNDLINK 3 1.3.0 IOS
Sbo Hearing A/S
269356
In Commercial Distribution

  • 05714464133963 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.3.0 IOS
Sbo Hearing A/S
269354
In Commercial Distribution

  • 05714464133949 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.3.0 IOS
Sbo Hearing A/S
269352
In Commercial Distribution

  • 05714464133925 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.3.0 IOS
Sbo Hearing A/S
269348
In Commercial Distribution

  • 05714464133888 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.2.0 IOS
Sbo Hearing A/S
265712
In Commercial Distribution

  • 05714464127214 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.2.0 IOS
Sbo Hearing A/S
265710
In Commercial Distribution

  • 05714464127191 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.2.0 IOS
Sbo Hearing A/S
265702
In Commercial Distribution

  • 05714464127139 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.1.0 IOS
Sbo Hearing A/S
264790
In Commercial Distribution

  • 05714464125241 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.1.0 IOS
Sbo Hearing A/S
264786
In Commercial Distribution

  • 05714464125203 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.1.0 IOS
Sbo Hearing A/S
264784
In Commercial Distribution

  • 05714464125180 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.1.0 IOS
Sbo Hearing A/S
264782
In Commercial Distribution

  • 05714464125166 ()


  • Hearing aid/implant system remote control
REMOTELINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215188
In Commercial Distribution

  • 05714464004645 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.1.0 IOS
Sbo Hearing A/S
214715
In Commercial Distribution

  • 05714464003617 ()


  • 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
REMOTELINK 2 1.4.0 IOS
Sbo Hearing A/S
270490
In Commercial Distribution

  • 05714464139446 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.4.0 IOS
Sbo Hearing A/S
270489
In Commercial Distribution

  • 05714464139439 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.5.0 IOS
Sbo Hearing A/S
274919
In Commercial Distribution

  • 05714464146109 ()


  • Hearing aid/implant system remote control
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 REMOTECARE 3.5.0 IOS
Sbo Hearing A/S
247221
In Commercial Distribution

  • 05714464060313 ()


  • Hearing aid/implant system remote control
REMOTELINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246114
In Commercial Distribution

  • 05714464059805 ()


  • Hearing aid/implant system remote control
Oticon Companion 1.0.0 iOS
Sbo Hearing A/S
243486
In Commercial Distribution

  • 05714464059331 ()


  • Hearing aid/implant system remote control
SoundLink 3 1.0.0 iOS
Sbo Hearing A/S
242486
In Commercial Distribution

  • 05714464058976 ()


  • Hearing aid/implant system remote control
RemoteLink 2 1.0.0 iOS
Sbo Hearing A/S
242484
In Commercial Distribution

  • 05714464058952 ()


  • Hearing aid/implant system remote control
Bernafon App 1.0.0 iOS
Sbo Hearing A/S
242482
In Commercial Distribution

  • 05714464058938 ()


  • Hearing aid/implant system remote control
IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software
SOUNDLINK 2 1.8 IOS
Sonic Innovations, Inc.
185787
In Commercial Distribution

  • 05711583030142 ()


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

  • 05706069702958 ()
5 300 0016 001

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

  • 05706069930313 ()
5 300 0021 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
iCare PATIENT2 (iOS version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851098 ()


  • Medical equipment clinical data interfacing software
WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
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