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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BMS CT360 Android Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Android Patient App
Not in Commercial Distribution

  • 00851203006234 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00643169491748 ()


  • ENT stereotactic surgery system
SW APP A901 COMM MANAGER
MEDTRONIC, INC.
A901
In Commercial Distribution

  • 00643169738058 ()


  • Multiple active implantable device programmer
SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00643169738041 ()


  • Multiple active implantable device programmer
Sony | Hearing Control App WA
Ws Audiology Usa, Inc.
Sony | Hearing Control WA
In Commercial Distribution

  • 05714880199420 ()
21026345

  • Audiometric/hearing device software
Android Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007465 ()
Lexie Android App

  • Audiometric/hearing device software
IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software
APP WIDEX REMOTE CARE ANDROID
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779714 ()
21035228

  • Hearing aid/implant system remote control
APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control
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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