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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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Specialized user interface software
INTERSON CORP
x.x
In Commercial Distribution

  • 00850921007189 ()


  • General-purpose ultrasound imaging system
Monitor communication software application
PREVENTICE TECHNOLOGIES, INC.
SW1003
In Commercial Distribution

  • 00852132007309 ()


  • Cardiopulmonary physiological parameter analysis software
Sleep Profiler Portal Software
ADVANCED BRAIN MONITORING, INC.
Sleep Profiler Portal Software
In Commercial Distribution

  • 00851113007024 ()


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

  • 00851113007017 ()


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

  • 00861334000315 ()
Mobius3D

  • Accelerator system quality assurance device
Patient Monitoring Software/System
Gastroklenz Inc.
04PD001
In Commercial Distribution

  • 00860006810238 ()


  • Peritoneal dialysis system
Dosimetry and QA Software
RADIOLOGICAL IMAGING TECHNOLOGY
113
In Commercial Distribution

  • 00857450006003 ()
RIT113

  • Accelerator system quality assurance device
DENTCA Design - DENTCA Software
DENTCA, INC.
DENTCA Design - Software
In Commercial Distribution

  • 00856551007506 ()


  • CAD/CAM software
PULSE Software, Base Image
Nuvasive, Inc.
1802489
In Commercial Distribution

  • 00195377065506 ()


  • Orthopaedic stereotactic surgery system
Orthex P&C Software
VILEX IN TENNESSEE, INC.
ORTHEXRPS
Not in Commercial Distribution

  • 00841731119209 ()


  • External orthopaedic fixation frame calculation software
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