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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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No Description
VERAN MEDICAL TECHNOLOGIES INC.
SFT-0007
Not in Commercial Distribution

  • 00815686021078 ()
SFT-0007

  • Virtual bronchoscopic navigation PACS software
Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz test.
Aktina Corp.
80-800
In Commercial Distribution

  • B3658080000 ()


  • Accelerator system quality assurance device
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SFT-0004
Not in Commercial Distribution

  • 00815686021061 ()
SFT-0004

  • Electromagnetic surgical navigation device tracking system
No Description
MEDTRAK VNG, INC.
M917081
In Commercial Distribution

  • B292M9170810 ()


  • Eye movement analysis system
No Description
Aktina Corp.
50-135
In Commercial Distribution

  • B365501350 ()


  • Stereotactic system application software
tremoFlo Airwave Oscillometry System software component (US Version). System to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
Thorasys Thoracic Medical Systems Inc
101345
In Commercial Distribution

  • 07540261013454 ()


  • Pulmonary function analysis system, adult
No Description
Thought Technology Ltd.
SA7900
In Commercial Distribution

  • 07540191000449 ()


  • Psychophysiological biofeedback system
No Description
Bio/Data Corporation
107153
In Commercial Distribution

  • G0561071530 ()
107053

  • Platelet aggregation analyser IVD
Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system
Holter Analysis Enhanced Plus
Northeast Monitoring, Inc.
Enhanced Plus
In Commercial Distribution

  • M581NEMK1620 ()
NEMK162

  • Cardiac arrhythmia monitoring system
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