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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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Kinesia 360 Support Application Software
Great Lakes Neurotechnologies Inc.
360-0048, Support Application Software
In Commercial Distribution

  • 00859584006171 ()


  • Tremor transducer
SOFTWARE 9733686 S7 SYNERGY SPINE
MEDTRONIC NAVIGATION, INC.
9733686
In Commercial Distribution

  • 00643169480957 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00643169503311 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE CD S0278-00 GRAV FIT
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169648975 ()


  • Audiometric/hearing device software
SOFTWARE 9735638 FUSION COMPACT ENT
MEDTRONIC NAVIGATION, INC.
9735638
In Commercial Distribution

  • 00643169693616 ()


  • ENT stereotactic surgery system
SOFTWARE CD S0278-00 NOAH FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169671553 ()


  • Audiometric/hearing device software
SOFTWARE EXECUTABLE, LUCAS Report Generator
PHYSIO-CONTROL, INC.
60600
In Commercial Distribution

  • 00883873851913 ()
60600-000145

  • Medical equipment clinical data interfacing software
NeuroWorks/SleepWorks 10.0.1 Software (US)
XLTEK
041904
In Commercial Distribution

  • 00382830061742 ()


  • Electroencephalograph
VIR SOFTWARE, EDX - EMG/ NCS
NATUS MANUFACTURING LIMITED
9033S0511
In Commercial Distribution

  • 00382830050999 ()
9033S0511

  • Electromyograph
Natus Elite v2 Software Update
NATUS NEUROLOGY INCORPORATED
688-630000
In Commercial Distribution

  • 00382830062268 ()


  • Electromyograph
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