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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EASYCONTROL-A 1.8 IOS
Bernafon AG
185786
In Commercial Distribution

  • 05711584083192 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.4 IOS
Bernafon AG
178496
In Commercial Distribution

  • 05711583029900 ()


  • Hearing aid/implant system remote control
Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software
REMOTEFIT 3.5.0 IOS
Sbo Hearing A/S
247219
In Commercial Distribution

  • 05714464060290 ()


  • Hearing aid/implant system remote control
RemoteFit 3.4.0 iOS
Sbo Hearing A/S
236790
In Commercial Distribution

  • 05714464042487 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.2 IOS
Oticon A/S
176636
In Commercial Distribution

  • 05707131328533 ()


  • Hearing aid/implant system remote control
COM-DEX app iOS
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599978 ()
5 300 0000 001

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

  • 05706069659689 ()
5 300 0003 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
REMOTELINK 2.1.0 IOS
Lehiso A/S
214712
Not in Commercial Distribution

  • 05713708000214 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.0 IOS
Lehiso A/S
204456
Not in Commercial Distribution

  • 05713708000177 ()


  • Hearing aid/implant system remote control
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