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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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The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
144-Channel Amplifier
Not in Commercial Distribution

  • EBCI70020 ()

  • Channel Number 144
7002

  • Multiple physiological signal amplifier
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
80-Channel Amplifier
In Commercial Distribution


  • Channel Number 80
7001

  • Multiple physiological signal amplifier
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
80-Channel Amplifier
Not in Commercial Distribution

  • EBCI70010 ()

  • Channel Number 80
7001

  • Multiple physiological signal amplifier
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
Ekso Bionics, Inc.
GT
In Commercial Distribution

  • B1431200000 ()


  • Programmable ambulation exoskeleton, clinical
The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measurements of cerebrovascular blood flow. Designed to exacting standards, Varia delivers excellent signal quality with minimal ambient noise, allowing clinicians to easily locate vessels and obtain high-quality measurements. When attached to an external MS Windows-based computer, Varia presents the clinician with an intuitive interface including clear displays and easy-to-use input parameters to facilitate a quality exam. Utilized with software only device accessory Varia-NCI.
NEUROCHAOS SOLUTIONS INC
1
In Commercial Distribution

  • B41278000 ()
7800

  • Noninvasive vascular ultrasound system, line-powered
  • Invasive vascular ultrasound system
A device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose. This kit contains an installation disc, USB cable and power supply, PSPs, barrier envelopes, barrier film rolls, PSP wipes, and a scanner cleaning sheet.
AIR TECHNIQUES, INC.
G8010
In Commercial Distribution

  • D678G80001 ()
  • D678G80100 ()
  • D678G80101 ()

  • Weight: 14.5 Pound
  • Outer Diameter: 9.6 Inch
  • Height: 9.2 Inch
  • Width: 8.9 Inch


  • Radiography digital imaging scanner
Web application
Medidata Solutions, Inc.
SW-0028
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Investigator application for Android
Medidata Solutions, Inc.
SW-0027
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Sync application for Android
Medidata Solutions, Inc.
SW-0026
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link application for Android
Medidata Solutions, Inc.
SW-0025
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
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