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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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Respiratory Module software module.
VISION RT LIMITED
Respiratory Module
Not in Commercial Distribution

  • 05056190500733 ()
Respiratory Module

  • Radiological video camera patient positioning/tracking system
SOFTWARE 9734383XOM STEALTHMERGE ENT
MEDTRONIC NAVIGATION, INC.
9734383XOM
Not in Commercial Distribution

  • 00643169491830 ()


  • Multi-purpose stereotactic surgery system
ClearPoint - Software Version 3.0
Clearpoint Neuro, Inc.
CP-SFW-11-30
In Commercial Distribution

  • 00850047354099 ()
CP-SFW-11-30

  • Neurological stereotactic surgery system
SOFTWARE 9733986 FRAMELINK S7
MEDTRONIC NAVIGATION, INC.
9733986
In Commercial Distribution

  • 00643169363540 ()


  • Multi-purpose stereotactic surgery system
Sleep Profiler RTA Software
ADVANCED BRAIN MONITORING, INC.
SP42-5402
In Commercial Distribution

  • 00850015266706 ()


  • Polysomnography analyser
Cytolink 1.0 Software DVD
Leica Biosystems Richmond, Inc.
23SW0001LNK
Not in Commercial Distribution

  • 00849832011569 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
SenSmart Data Management software
NONIN MEDICAL, INC.
SenSmart Download Software
In Commercial Distribution

  • 00849686074796 ()
  • 00849686072617 ()


  • Medical equipment clinical data interfacing software
PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333247417 ()


  • Speech assistive training device
COMPUTERIZED SPEECH LAB (SOFTWARE)
PENTAX OF AMERICA, INC.
4500B
In Commercial Distribution

  • 04961333236589 ()


  • Speech assistive training device
PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333236565 ()


  • Electroglottograph
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