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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APP,AUDIGY ATTUNE,1.2,IOS
Gn Hearing A/S
20789000
In Commercial Distribution

  • 05708296097241 ()


  • Hearing aid/implant system remote control
APP,TUNER,TRUHEARING,3.5,ANDR
Gn Hearing A/S
20681500
In Commercial Distribution

  • 05708296095575 ()


  • Hearing aid/implant system remote control
APP,TUNER,TRUHEARING,3.5,IOS
Gn Hearing A/S
20681400
In Commercial Distribution

  • 05708296095568 ()


  • Hearing aid/implant system remote control
APP,GNH BEMORE,1.1,ANDR
Gn Hearing A/S
20664000
In Commercial Distribution

  • 05708296095308 ()


  • Hearing aid/implant system remote control
APP,GNH BEMORE,1.1,IOS
Gn Hearing A/S
20663900
In Commercial Distribution

  • 05708296095292 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,3.2.2,ANDR
Gn Hearing A/S
20425500
In Commercial Distribution

  • 05708296076703 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,3.2.2,IOS
Gn Hearing A/S
20425400
In Commercial Distribution

  • 05708296076697 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,4.0,ANDR
Gn Hearing A/S
20993700
In Commercial Distribution

  • 05708296158478 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,4.0,IOS
Gn Hearing A/S
20993600
In Commercial Distribution

  • 05708296158461 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,4.0,ANDR
Gn Hearing A/S
20993500
In Commercial Distribution

  • 05708296158454 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,4.0,IOS
Gn Hearing A/S
20993400
In Commercial Distribution

  • 05708296158447 ()


  • Hearing aid/implant system remote control
APP,RS SMART,4.0,ANDR
Gn Hearing A/S
20993300
In Commercial Distribution

  • 05708296158430 ()


  • Hearing aid/implant system remote control
APP,RS SMART,4.0,IOS
Gn Hearing A/S
20993200
In Commercial Distribution

  • 05708296158423 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,4.0,ANDR
Gn Hearing A/S
20993100
In Commercial Distribution

  • 05708296158416 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,4.0,IOS
Gn Hearing A/S
20993000
In Commercial Distribution

  • 05708296158409 ()


  • Hearing aid/implant system remote control
SFTWR 9730896 CRANIAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730896
In Commercial Distribution

  • 00721902865572 ()


  • Multi-purpose stereotactic surgery system
iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software
Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software
J TONG MED/LGE-No App
OSSUR AMERICAS, INC.
JT-115
Not in Commercial Distribution

  • 05690977308701 ()
JT-115

  • Traction system skull tongs
Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674729 ()
5 300 0007 001

  • Tinnitus masking application software
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