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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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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
ClearPoint - Software Version 3.0
Clearpoint Neuro, Inc.
CP-SFW-11-30
In Commercial Distribution

  • 00850047354099 ()
CP-SFW-11-30

  • Neurological stereotactic surgery system
PR Software OEM Embedded
Mindset Medical Inc.
PROEMEMB
In Commercial Distribution

  • 00850070776028 ()


  • Camera application software
SOFTWARE 8870AAV01 N'VISION US
MEDTRONIC, INC.
8870AAV01
In Commercial Distribution

  • 00643169955653 ()


  • Multiple active implantable device programmer
ClearPoint Software Version 2.2
Clearpoint Neuro, Inc.
CP-SFW-11-22
In Commercial Distribution

  • 00850376007888 ()
CP-SFW-11-22

  • Neurological stereotactic surgery system
ClearPoint Software Version 2.1
Clearpoint Neuro, Inc.
CP-SFW-11-21
In Commercial Distribution

  • 00850376007703 ()
CP-SFW-11-21

  • Neurological stereotactic surgery system
Spinal surgery planning software
S.M.A.I.O
V2.0.0
In Commercial Distribution

  • 03701313007935 ()


  • Radiological PACS software
Spinal surgery planning software
S.M.A.I.O
V1.1.X
Not in Commercial Distribution

  • 03701313000479 ()


  • Radiological PACS software
Holter Analysis Software Apnea
Northeast Monitoring, Inc.
Holter Analysis Software Apnea
In Commercial Distribution

  • M582NEMK1270 ()
M582NEMK127

  • Cardiac arrhythmia monitoring system
INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software
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