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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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Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 4.1 SOFTWARE - CAM
COCHLEAR LIMITED
Z494179
In Commercial Distribution

  • 09321502029469 ()
Z494179

  • Audiometric/hearing device software
Grael v2 System with PSG software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001771 ()
9028-0002-02

  • Polysomnograph
Somte Recording System Compumedics, no Software
COMPUMEDICS LIMITED
Somte
In Commercial Distribution

  • 09342451001733 ()
9012-0003-01

  • Polysomnograph
Somte PSG v2 System, No software
COMPUMEDICS LIMITED
Somte PSG v2
In Commercial Distribution

  • 09342451001368 ()
9023-0002-01

  • Polysomnograph
Grael EEG v2 System - no software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001252 ()
9028-0003-02

  • Electroencephalograph
Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system
VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.1
In Commercial Distribution

  • 09421904268166 ()


  • Radiology DICOM image processing application software
VolparaDensity 3.2 (Volpara Imaging Software 1.5.2)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.2
Not in Commercial Distribution

  • 09421904268029 ()


  • Radiology DICOM image processing application software
Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software
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