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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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Leica Biosystems CytoVision Karyotyping Software Upgrade
Leica Biosystems Richmond, Inc.
23SWR001KLX001
Not in Commercial Distribution

  • 00849832003670 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Cardiac MR & CT imaging software application
Circle Cardiovascular Imaging Inc
5.6
In Commercial Distribution

  • 00882916000004 ()


  • MRI system application software
SOFTWARE COMP GPS 4.7 USB PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239140 ()
21038004

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.7 DVD PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239133 ()
21038003

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.8 USB PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256772 ()
21041975

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.8 DVD PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256765 ()
21041974

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.5 DVD PACKAGE
Widex A/S
Compass GPS 4.5
In Commercial Distribution

  • 05714880204070 ()
21027791

  • Audiometric/hearing device software
OARtrac Proprietary System Software for CDU
RADIADYNE, L.L.C.
OT-PSS
In Commercial Distribution

  • 00851546007097 ()
OT-PSS

  • MOSFET radiation therapy dosimetry system
Software for Messaging Controller, Version 1.8.7
AMPLION CLINICAL COMMUNICATIONS, INC.
S-MGC-187-1
Not in Commercial Distribution

  • 00850016398352 ()
S-MGC-187-1

  • Nurse call system
2 PCS MER3400 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MER3400
In Commercial Distribution

  • 05415067037121 ()
MER3400

  • Implantable cardiac device management application software
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