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

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system
Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software
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
SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD
MEDTRONIC XOMED, INC.
8263005
In Commercial Distribution

  • 00613994161635 ()


  • Nerve-locating system
SOFTWARE MMT-7335 CD-ROM CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00613994342805 ()


  • Patient health record information system application software
SWR KIT SSPRO SOFTWARE VER 11
VYAIRE MEDICAL, INC.
28008-001
In Commercial Distribution

  • 10190752161993 ()
28008-001

  • Home-use sleep apnoea recording system
Sleepware G3 Software Package, Multi Lingual
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004856 ()
1082463

  • Polysomnography analyser
HL7 Software for Sleepware G3, Web
Respironics, Inc.
3.1
In Commercial Distribution

  • 00606959038967 ()
1117948

  • Clinical laboratory information system
Grael v2 System with PSG software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001771 ()
9028-0002-02

  • Polysomnograph
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