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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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300, 400, 500 Series Restorative Instrument Kit
Implant Logistics, Inc.
KIT-REIN-00
In Commercial Distribution

  • D762KITREIN000 ()


  • Dental torque wrench
  • Surgical screwdriver, reusable
  • Dental implant extractor
Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Terarecon Inc.
Eureka AI Results Explorer
In Commercial Distribution

  • B2208430011 ()


  • Radiology DICOM image processing application software
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000A PRO
In Commercial Distribution

  • B510PM2000APRO1 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000A
In Commercial Distribution

  • B510PM2000A1 ()


  • Multiple vital physiological parameter monitoring system, clinical
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
16-Channel Amplifier
In Commercial Distribution

  • EBCI7092US0 ()

  • Channel Number 16
7092US

  • 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
32-Channel Amplifier
In Commercial Distribution

  • EBCI7091US0 ()

  • Channel Number 16
7091US

  • 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
256-Channel Amplifier
In Commercial Distribution


  • Channel Number 256
7003

  • 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
256-Channel Amplifier
Not in Commercial Distribution

  • EBCI70030 ()

  • Channel Number 256
7003

  • 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
144-Channel Amplifier
In Commercial Distribution


  • 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
144-Channel Amplifier
Not in Commercial Distribution

  • EBCI70020 ()

  • Channel Number 144
7002

  • Multiple physiological signal amplifier
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