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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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Version 15.0
Philips Ultrasound LLC
989606710071
In Commercial Distribution

  • 00884838098220 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
Release 10.8.5
In Commercial Distribution

  • 00884838086616 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
Release 3.8
In Commercial Distribution

  • 00884838083509 ()


  • Radiological PACS software
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
ASSOCIATES OF CAPE COD, INC.
0
In Commercial Distribution

  • 00862696000289 ()


  • Laboratory instrument/analyser application software IVD
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution

  • 00865435000311 ()
SCIII SW

  • Heater/cooler system tester kit
VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000223 ()


  • Radiological PACS software
No Description
ORTHO KINEMATICS, INC.
2.3
In Commercial Distribution

  • 00868579000216 ()


  • Radiological PACS software
No Description
Archform Inc.
Various
In Commercial Distribution

  • 00860012168521 ()
2

  • CAD/CAM software
No Description
Virtual Vision Health
3.2.0
In Commercial Distribution

  • 00860010709795 ()
VV-021

  • Perimeter, automatic
No Description
Virtual Vision Health
3.1.0
In Commercial Distribution

  • 00860010709788 ()


  • Perimeter, automatic
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