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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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Vocal Parts and Vocal Pathology I & II Software
PENTAX OF AMERICA, INC.
9225
In Commercial Distribution

  • 04961333230358 ()


  • Electroglottograph
Software unitary component (common to hip and knee)
Omni Life Science, Inc.
TOOL 14-020
In Commercial Distribution

  • 00841690194019 ()
TOOL 14-020

  • Robotic surgical navigation system application software
ALPHA MULTISTORE ACQUISITION BOX HD INCLUSIVE SOFTWARE "PERSONAL"
Gimmi GmbH
S.2046.60 HD
In Commercial Distribution

  • 04049047653516 ()
S.2046.60 HD

  • Endoscopic video imaging system
EMG v22 to Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630300
In Commercial Distribution

  • 00382830045070 ()


  • Electromyograph
Aurora Xi Plasmapheresis System with Software Version 2.0
Fresenius Kabi AG
Software Version 2.0
In Commercial Distribution

  • 00810020442199 ()


  • Apheresis system
Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.122.0
In Commercial Distribution

  • 00810020441192 ()


  • Apheresis system
Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.113.0
In Commercial Distribution

  • 00810020440607 ()


  • Apheresis system
Aurora Xi Plasmapheresis System with Software Version 2.1
Fresenius Kabi AG
Software Version 2.1
In Commercial Distribution

  • 00810020440560 ()


  • Apheresis system
Software version for AMICUS Separator life extension device
Fresenius Kabi AG
6.0
In Commercial Distribution

  • 00810020440171 ()


  • Apheresis system
VP 2000 System Software v2.1 with Protocols USB
ABBOTT MOLECULAR INC.
02J11-057
In Commercial Distribution

  • 00884999048478 ()
02J11-057

  • Tissue processor IVD, automated/semi-automated
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