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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OTICON ON 1.8 IOS
Oticon A/S
185783
In Commercial Distribution

  • 05707131335074 ()


  • Hearing aid/implant system remote control
Oticon RemoteCare 3.3.0 iOS
Sbo Hearing A/S
228209
In Commercial Distribution

  • 05714464012930 ()


  • Hearing aid/implant system remote control
RemoteLink Connect 3.3.0 iOS
Sbo Hearing A/S
228203
In Commercial Distribution

  • 05714464012879 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.5.0 IOS
Sbo Hearing A/S
228198
In Commercial Distribution

  • 05714464012824 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.5.0 IOS
Sbo Hearing A/S
228196
In Commercial Distribution

  • 05714464012800 ()


  • Hearing aid/implant system remote control
OTICON ON 2.5.0 IOS
Sbo Hearing A/S
228193
In Commercial Distribution

  • 05714464012770 ()


  • Hearing aid/implant system remote control
OTICON ON 2.4.0 IOS
Sbo Hearing A/S
226657
In Commercial Distribution

  • 05714464012275 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.4.0 IOS
Sbo Hearing A/S
226431
In Commercial Distribution

  • 05714464012084 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.4.0 IOS
Sbo Hearing A/S
226429
In Commercial Distribution

  • 05714464012060 ()


  • Hearing aid/implant system remote control
OTICON ON 2.3.0 IOS
Sbo Hearing A/S
224170
In Commercial Distribution

  • 05714464011612 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.3.0 IOS
Sbo Hearing A/S
220593
In Commercial Distribution

  • 05714464011308 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.3.0 IOS
Sbo Hearing A/S
220591
In Commercial Distribution

  • 05714464011285 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.1.0 IOS
Sbo Hearing A/S
219643
In Commercial Distribution

  • 05714464006458 ()


  • 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 RemoteCare 3.4.0 iOS
Sbo Hearing A/S
236788
In Commercial Distribution

  • 05714464042463 ()


  • Hearing aid/implant system remote control
RemoteLink Connect 3.4.0 iOS
Sbo Hearing A/S
234034
In Commercial Distribution

  • 05714464034673 ()


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

  • 05714464127139 ()


  • 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 1.1.0 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
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 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 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
Beyond App iOS 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689105 ()
5 300 0008 001

  • 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
DreamMapper iOS China Instance
Respironics, Inc.
DreamMapper iOS, China Instance - 2
Not in Commercial Distribution

  • 00606959057722 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper App iOS (APAC)
Respironics, Inc.
DreamMapper App iOS, Asia-Pacific Instance - 2
In Commercial Distribution

  • 00606959057715 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS (EMEA)
Respironics, Inc.
DreamMapper Mobile App iOS EMEA - 2
In Commercial Distribution

  • 00606959057708 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper App iOS (APAC)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048584 ()
1127959

  • Self-care monitoring/reporting software
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