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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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NA - 04931921100783

EEG examination support software
NIHON KOHDEN CORPORATION
QP-150AK
In Commercial Distribution

  • 04931921100783 ()
QP-150AK

  • Electroencephalograph

N/A - 00613994446060

SOFTWARE 9733877 STEALTHVIZ LINUX
MEDTRONIC NAVIGATION, INC.
9733877
In Commercial Distribution

  • 00613994446060 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994446053

SOFTWARE 9733878 STEALTHVIZ WIN32
MEDTRONIC NAVIGATION, INC.
9733878
In Commercial Distribution

  • 00613994446053 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994445988

SOFTWARE 9733760 CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733760
In Commercial Distribution

  • 00613994445988 ()


  • Neurological stereotactic surgery system

N/A - 00613994776730

SOFTWARE 9734620 MACH POLESTAR
MEDTRONIC NAVIGATION, INC.
9734620
In Commercial Distribution

  • 00613994776730 ()


  • Stereotactic surgery system probe, reusable

N/A - 00613994596826

SOFTWARE 9734220 MACH POLESTAR
MEDTRONIC NAVIGATION, INC.
9734220
In Commercial Distribution

  • 00613994596826 ()


  • Neurological stereotactic surgery system

N/A - 00613994099488

SOFTWARE 9732811 MICROCAL PLUS
MEDTRONIC NAVIGATION, INC.
9732811
In Commercial Distribution

  • 00613994099488 ()


  • Multi-purpose stereotactic surgery system

RIT - 00857450006003

Dosimetry and QA Software
RADIOLOGICAL IMAGING TECHNOLOGY
113
In Commercial Distribution

  • 00857450006003 ()
RIT113

  • Accelerator system quality assurance device

Messenger - 00865190000304

Messenger 5.18 Software Release
SPOK INC.
5.18.0
In Commercial Distribution

  • 00865190000304 ()


  • Alarm application software

EnsoSleep - 00864458000407

Automated sleep scoring software.
ENSODATA, INC.
01.1
Not in Commercial Distribution

  • 00864458000407 ()


  • Sleep disorder interpretive software, professional-only
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