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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MOTION INTELLIGENCE APP
DJO, LLC
13-4024
In Commercial Distribution

  • 00190446293613 ()

  • UNIV


  • Kinesiology ambulatory recorder
Support App (Palma)
Advanced Bionics, LLC
CI-6517
In Commercial Distribution

  • 00840094491007 ()


  • Audiometric/hearing device software
Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution


  • No size - Software as a Medical Device
N/A

  • Clinical management support software
Arial Mobile App
Securitas Healthcare LLC
54600
In Commercial Distribution

  • 00840948100963 ()


  • Alarm application software
Therapy Controller App
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5275
In Commercial Distribution

  • 00191506020705 ()


  • Implantable spinal cord electrical stimulation system programmer
APP (Pads only)
COMPASS HEALTH BRANDS CORP.
SA901P
Not in Commercial Distribution

  • 00841447104070 ()
SA901P

  • Air-filled bed mattress overlay
Dialogue AAC App
PRENTKE ROMICH COMPANY
Dialogue App
In Commercial Distribution

  • 00816486021183 ()
18312

  • Voice synthesizer/digitizer
TouchChat HD App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021053 ()
18626-4

  • Voice synthesizer/digitizer
Classic TouchChat App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021022 ()
18626-0

  • Voice synthesizer/digitizer
myPhonak Junior app
Sonova AG
088-0017
In Commercial Distribution

  • 07613389477283 ()
088-0017

  • Audiometric/hearing device software
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