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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 flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
KA Imaging Inc
1
Not in Commercial Distribution

  • 16280119411015 ()
101

  • Indirect flat panel x-ray detector
NeoNavia base unit
NeoDynamics AB (publ)
1102
Not in Commercial Distribution

  • 27350081940083 ()
  • 17350081940086 ()
1102

  • Mammographic stereotactic biopsy system
NeoNavia driver
NeoDynamics AB (publ)
1103
Not in Commercial Distribution

  • 27350081940045 ()
  • 17350081940048 ()
  • 37350081940042 ()
1103

  • Mammographic stereotactic biopsy system
Oculogica’s EyeBOX uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near- infrared (IR) camera records gaze positions. The post-processed data are analyzed automatically to produce one or more outcome measures. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm. The EyeBOX device tracks a patient’s eye movement and calculates a BOX Score ranging from 0-20. A score of less than 10 is a negative result, while a score of greater than or equal to 10 indicates a positive result.
Oculogica Inc.
OCL 02.5
In Commercial Distribution

  • 00810051680003 ()


  • Eye-tracking neurological/brain injury assessment device
Fluid status monitor This catalog item is used by a health care provider in the hospital, hospital like facilities and home setting
SENSIBLE MEDICAL INNOVATIONS LTD
V2.7
Not in Commercial Distribution

  • 07290110070144 ()
GAS0046

  • Whole-body plethysmograph
Fluid status monitor This catalog item may also be used by a health care provider, in the hospital or hospital like facilities, to obtain spot readings of multiple patients.
SENSIBLE MEDICAL INNOVATIONS LTD
V2.6
Not in Commercial Distribution

  • 07290110070120 ()
GAS0045

  • Whole-body plethysmograph
Fluid Status Monitor
SENSIBLE MEDICAL INNOVATIONS LTD
V2.6
Not in Commercial Distribution

  • 07290110070090 ()
GAS0035

  • Whole-body plethysmograph
Fluid status monitor This catalog item may also be used by a health care provider, in the hospital or hospital like facilities, to obtain spot readings of multiple patients.
SENSIBLE MEDICAL INNOVATIONS LTD
V2.6
Not in Commercial Distribution

  • 07290110070045 ()
GAS0045

  • Whole-body plethysmograph
Fluid Status Monitor
SENSIBLE MEDICAL INNOVATIONS LTD
V2.6
Not in Commercial Distribution

  • 07290110070014 ()
GAS0035

  • Whole-body plethysmograph
Fluid status monitor This catalog item is used by a health care provider in the hospital, hospital like facilities and home setting
SENSIBLE MEDICAL INNOVATIONS LTD
V2.7
In Commercial Distribution

  • 07290110070540 ()
GAS0047-R

  • Whole-body plethysmograph
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