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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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
Nucleus Smart App
COCHLEAR LIMITED
P1285539
In Commercial Distribution

  • 09321502043236 ()
P1285539

  • Audiometric/hearing device software
G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
APP (Pads only)
COMPASS HEALTH BRANDS CORP.
SA901P
Not in Commercial Distribution

  • 00841447104070 ()
SA901P

  • Air-filled bed mattress overlay
SmartView Connect App
MICROPORT CRM SRL
SW001U
In Commercial Distribution

  • 08031527019932 ()
SW001U

  • Cardiology information system application software
Support App (Palma)
Advanced Bionics, LLC
CI-6517
In Commercial Distribution

  • 00840094491007 ()


  • Audiometric/hearing device software
Holter Mobile App
Lifesignals, Inc.
UA2251-R
In Commercial Distribution

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software
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
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