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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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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

Mobius3D - 00861334000315

Secondary Check QA Software
VARIAN MEDICAL SYSTEMS, INC.
2.0.1
Not in Commercial Distribution

  • 00861334000315 ()
Mobius3D

  • Accelerator system quality assurance device

ECG Plug-In - 00852132007309

Monitor communication software application
PREVENTICE TECHNOLOGIES, INC.
SW1003
In Commercial Distribution

  • 00852132007309 ()


  • Cardiopulmonary physiological parameter analysis software

SOTA Cloud Imaging - 00851159007125

Dental Cloud Imaging Software
SOTA PRECISION OPTICS, INC.
1
In Commercial Distribution

  • 00851159007125 ()


  • General-purpose dental x-ray system application software

Sleep Profiler - 00851113007024

Sleep Profiler Portal Software
ADVANCED BRAIN MONITORING, INC.
Sleep Profiler Portal Software
In Commercial Distribution

  • 00851113007024 ()


  • Polysomnography analyser

Sleep Profiler - 00851113007017

Sleep Profiler Desktop Software
ADVANCED BRAIN MONITORING, INC.
Sleep Profiler Desktop Software
In Commercial Distribution

  • 00851113007017 ()


  • Polysomnography analyser

TigerView - 00851800007108

TigerView software version 8.4.1
TELEVERE SYSTEMS, LLC
8.4.1
In Commercial Distribution

  • 00851800007108 ()
TigerView 8.4.1

  • Basic diagnostic x-ray system application software
  • Camera application software
  • Multidisciplinary medical image management software
  • General-purpose dental x-ray system application software
  • Radiological PACS software

TigerView - 00851800007085

TigerView software version 8.2
TELEVERE SYSTEMS, LLC
8.2
In Commercial Distribution

  • 00851800007085 ()
TigerView 8.2

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software

TigerView - 00851800007061

TigerView software version 8.3
TELEVERE SYSTEMS, LLC
8.3
In Commercial Distribution

  • 00851800007061 ()
TigerView 8.3

  • Basic diagnostic x-ray system application software
  • Camera application software
  • Multidisciplinary medical image management software
  • General-purpose dental x-ray system application software
  • Radiological PACS software

Visix - 00851800007030

Visix software version 2.3.9
TELEVERE SYSTEMS, LLC
2.3.9
In Commercial Distribution

  • 00851800007030 ()
Visix 2.3.9

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software

StealthStation® Cranial - 00643169625532

SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00643169625532 ()


  • Neurological stereotactic surgery system

N/A - 00643169491830

SOFTWARE 9734383XOM STEALTHMERGE ENT
MEDTRONIC NAVIGATION, INC.
9734383XOM
Not in Commercial Distribution

  • 00643169491830 ()


  • Multi-purpose stereotactic surgery system
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