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 2 2.0 IOS
Sonic Innovations, Inc.
204547
In Commercial Distribution

  • 05711583037455 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.10 IOS
Sonic Innovations, Inc.
199525
In Commercial Distribution

  • 05711583037417 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.1.0 IOS
Sonic Innovations, Inc.
214710
In Commercial Distribution

  • 05711583038216 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.4 IOS
Sonic Innovations, Inc.
178497
In Commercial Distribution

  • 05711584074695 ()


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

  • 05706069689105 ()
5 300 0008 001

  • Hearing aid/implant system remote control
OTICON ON 1.4 IOS
Oticon A/S
178493
In Commercial Distribution

  • 05707131329981 ()


  • Hearing aid/implant system remote control
ON APP 1.2 IOS
Oticon A/S
176634
In Commercial Distribution

  • 05707131328519 ()


  • Hearing aid/implant system remote control
TempTraq Patient iOS App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006371 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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