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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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SOFTWARE 9733808 DICOM Q/R
MEDTRONIC NAVIGATION, INC.
9733808
In Commercial Distribution

  • 00613994467089 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9734400XOM STEALTHMERGE ENT PG
MEDTRONIC NAVIGATION, INC.
9734400XOM
In Commercial Distribution

  • 00613994680891 ()


  • Multi-purpose stereotactic surgery system
ORTHOMAP¿ EXPRESS KNEE 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-672-000
In Commercial Distribution

  • 04546540717450 ()
6003-672-000

  • Robotic surgical navigation system application software
ORTHOMAP¿ PRECISION KNEE 5.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-655-000
In Commercial Distribution

  • 04546540717443 ()
6003-655-000

  • Robotic surgical navigation system application software
Nueroscience for Human Communication, Software
PENTAX OF AMERICA, INC.
5155
In Commercial Distribution

  • 04961333229864 ()


  • Electroglottograph
Phonetic & Perception Simulation Program, Software
PENTAX OF AMERICA, INC.
5151
Not in Commercial Distribution

  • 04961333229826 ()


  • Electroglottograph
Multi-Dimensional Voice Program (MDVP) Software
PENTAX OF AMERICA, INC.
5105
In Commercial Distribution

  • 04961333229741 ()


  • Electroglottograph
HITACHI 5.1 SOFTWARE UPGRADE PREIRUS
PENTAX OF AMERICA, INC.
HITACHI5.1UPGRD
In Commercial Distribution

  • 04961333243105 ()


  • General-purpose ultrasound imaging system
Leica Biosystems Ariol Review Software
Leica Biosystems Richmond, Inc.
23ASWREV001
In Commercial Distribution

  • 00849832003830 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Software Application 3X version onwards
Vave Health, Inc.
VA-0303
In Commercial Distribution

  • 00850001977104 ()


  • Hand-held ultrasound imaging system, body-surface
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