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

  • 00852132007309 ()


  • Cardiopulmonary physiological parameter analysis software
Dental Cloud Imaging Software
SOTA PRECISION OPTICS, INC.
1
In Commercial Distribution

  • 00851159007125 ()


  • General-purpose dental x-ray system application 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
PACS Scan Software CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007112 ()


  • Radiography digital imaging scanner
ClearPoint - Software Version 2.0.2
Clearpoint Neuro, Inc.
CP-SFW-11-202
In Commercial Distribution

  • 00850359007768 ()
CP-SFW-11-202

  • Neurological stereotactic surgery system
ClearPoint - Software Version 2.0.1
Clearpoint Neuro, Inc.
CP-SFW-11-201
In Commercial Distribution

  • 00850359007751 ()
CP-SFW-11-201

  • Neurological stereotactic surgery system
ClearPoint - Software Version 1.6.2
Clearpoint Neuro, Inc.
CP-SFW-11-162
In Commercial Distribution

  • 00850359007614 ()
CP-SFW-11-162

  • Neurological stereotactic surgery system
ClearPoint - Software Version 2.0
Clearpoint Neuro, Inc.
CP-SFW-11-20
In Commercial Distribution

  • 00850359007607 ()
CP-SFW-11-20

  • Neurological stereotactic surgery system
ClearPoint - Software Version 2.0.3
Clearpoint Neuro, Inc.
CP-SFW-11-203
In Commercial Distribution

  • 00850359007003 ()
CP-SFW-11-203

  • Neurological stereotactic surgery system
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