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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 - 00850359007768

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 - 00850359007751

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 - 00850359007614

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 - 00850359007607

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 - 00850359007003

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 - 00850376007888

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 - 00850376007703

ClearPoint Software Version 2.1
Clearpoint Neuro, Inc.
CP-SFW-11-21
In Commercial Distribution

  • 00850376007703 ()
CP-SFW-11-21

  • Neurological stereotactic surgery system

DENTCA Design - 00856551007506

DENTCA Design - DENTCA Software
DENTCA, INC.
DENTCA Design - Software
In Commercial Distribution

  • 00856551007506 ()


  • CAD/CAM software

Vital-Trac - 00850070776028

PR Software OEM Embedded
Mindset Medical Inc.
PROEMEMB
In Commercial Distribution

  • 00850070776028 ()


  • Camera application software

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
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