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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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CNS Envision - B485VIS100

Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
MOBERG RESEARCH INC
VIS-100
In Commercial Distribution

  • B485VIS100 ()


  • Bioelectrical signal analysis software

CNS Envision - B485CNSENV1000

Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
NATUS NEUROLOGY INCORPORATED
1.03.00
In Commercial Distribution

  • B485CNSENV1000 ()


  • Bioelectrical signal analysis software

GoCheck Audiometric Headphone Assembly - B43061000060

Audiometric Headphone Final Assembly
Gobiquity, Inc.
Sennheiser HD280 Pro
In Commercial Distribution

  • B43061000060 ()


  • Tone audiometer

GoCheck - B43056000011000

Mobile Application for Hearing Screening
Gobiquity, Inc.
Hearing Mobile App V1.0.0
In Commercial Distribution

  • B43056000011000 ()


  • Tone audiometer

BC - B202BC0

No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software)
In Commercial Distribution

  • B202BC0 ()
BC

  • Bioelectrical signal analysis software

BC - B202BCSEG0

No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software) Segmental
In Commercial Distribution

  • B202BCSEG0 ()
BCSEG

  • Bioelectrical signal analysis software

NONE - B006EMGVIEW0

No Description
Neurovision Medical Products, Inc.
NONE
In Commercial Distribution

  • B006EMGVIEW0 ()


  • Bioelectrical signal analysis software

HeartVista Cardiac Package - B440HVCP030

HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution

  • B440HVCP030 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software

HeartVista Cardiac Package - B440HVCP020

HeartVista Cardiac Package
Heartvista, Inc.
020301
In Commercial Distribution

  • B440HVCP020 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software

JEDMED - M6333974203P0

HANDLE & CHARGER F/HORUS SERIES 3P
JEDMED INSTRUMENT COMPANY
39-7420-3P
In Commercial Distribution

  • M6333974203P0 ()
39-7420-3P

  • Ophthalmic fundus camera
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