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 Version 6.X
Philips Ultrasound LLC
795185
In Commercial Distribution

  • 00884838114463 ()


  • General-purpose ultrasound imaging system
Software Version 6.X
Philips Ultrasound LLC
795187
In Commercial Distribution

  • 00884838114456 ()


  • General-purpose ultrasound imaging system
Software version - 10.0.X
Philips Ultrasound LLC
795218
In Commercial Distribution

  • 00884838114197 ()


  • General-purpose ultrasound imaging system
Software version- 10.0.X
Philips Ultrasound LLC
795210
In Commercial Distribution

  • 00884838114180 ()


  • General-purpose ultrasound imaging system
Software version - 10.0.X
Philips Ultrasound LLC
795208
In Commercial Distribution

  • 00884838114173 ()


  • General-purpose ultrasound imaging system
Software version- 10.0.X
Philips Ultrasound LLC
795190
In Commercial Distribution

  • 00884838114166 ()


  • General-purpose ultrasound imaging system
Software version- 10.0.X
Philips Ultrasound LLC
795234
In Commercial Distribution

  • 00884838114159 ()


  • General-purpose ultrasound imaging system
Software version 10.0.X
Philips Ultrasound LLC
795232
In Commercial Distribution

  • 00884838114142 ()


  • General-purpose ultrasound imaging system
Software version 10.0.X
Philips Ultrasound LLC
795231
In Commercial Distribution

  • 00884838114135 ()


  • General-purpose ultrasound imaging system
Software version - 10.0.x
Philips Ultrasound LLC
795202
In Commercial Distribution

  • 00884838114104 ()


  • General-purpose ultrasound imaging system
Software version - 10.0.x
Philips Ultrasound LLC
795200
In Commercial Distribution

  • 00884838114098 ()


  • General-purpose ultrasound imaging system
Software Version 9.x
Philips Ultrasound LLC
795125
In Commercial Distribution

  • 00884838113961 ()


  • General-purpose ultrasound imaging system
Software version 4.X
Philips Ultrasound LLC
795123
In Commercial Distribution

  • 00884838113947 ()


  • General-purpose ultrasound imaging system
Software version 3.x
Philips Ultrasound LLC
795123
In Commercial Distribution

  • 00884838113930 ()


  • General-purpose ultrasound imaging system
Software Version 9.x
Philips Ultrasound LLC
795122
In Commercial Distribution

  • 00884838113923 ()


  • General-purpose ultrasound imaging system
Software version 7.x
Philips Ultrasound LLC
795122
In Commercial Distribution

  • 00884838113916 ()


  • General-purpose ultrasound imaging system
Software version 9.X
Philips Ultrasound LLC
795121
In Commercial Distribution

  • 00884838113909 ()


  • General-purpose ultrasound imaging system
Software version 7.x
Philips Ultrasound LLC
795121
In Commercial Distribution

  • 00884838113893 ()


  • General-purpose ultrasound imaging system
Software Version 9.X
Philips Ultrasound LLC
795120
In Commercial Distribution

  • 00884838113886 ()


  • General-purpose ultrasound imaging system
Software version 9.X
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838113862 ()


  • General-purpose ultrasound imaging system
Software version 7.x
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838113855 ()


  • General-purpose ultrasound imaging system
Software Version 7.X
Philips Ultrasound LLC
795118
In Commercial Distribution

  • 00884838113831 ()


  • General-purpose ultrasound imaging system
Software Version 9.X
Philips Ultrasound LLC
795117
In Commercial Distribution

  • 00884838113824 ()


  • General-purpose ultrasound imaging system
Software version 3.X
Philips Ultrasound LLC
795116
In Commercial Distribution

  • 00884838113800 ()


  • General-purpose ultrasound imaging system
Software version 2.X
Philips Ultrasound LLC
795116
In Commercial Distribution

  • 00884838113794 ()


  • General-purpose ultrasound imaging system
Software version 5.X
Philips Ultrasound LLC
795114
In Commercial Distribution

  • 00884838113787 ()


  • General-purpose ultrasound imaging system
Software version 6.X
Philips Ultrasound LLC
795258
In Commercial Distribution

  • 00884838111004 ()


  • General-purpose ultrasound imaging system
Radiation therapy QA software.
SUN NUCLEAR CORP.
1216028
In Commercial Distribution

1216028

  • Radiation therapy software
SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00643169625532 ()


  • Neurological stereotactic surgery system
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
SOFTWARE 9734383XOM STEALTHMERGE ENT
MEDTRONIC NAVIGATION, INC.
9734383XOM
Not in Commercial Distribution

  • 00643169491830 ()


  • Multi-purpose stereotactic surgery system
Respiratory Module software module.
VISION RT LIMITED
Respiratory Module
Not in Commercial Distribution

  • 05056190500733 ()
Respiratory Module

  • Radiological video camera patient positioning/tracking 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
Sleep Profiler RTA Software
ADVANCED BRAIN MONITORING, INC.
SP42-5402
In Commercial Distribution

  • 00850015266706 ()


  • Polysomnography analyser
SOFTWARE 9734220 MACH POLESTAR
MEDTRONIC NAVIGATION, INC.
9734220
In Commercial Distribution

  • 00613994596826 ()


  • Neurological stereotactic surgery system
TRUST Dental CAD Software
Rgorithm Korea
V1.0
In Commercial Distribution

  • 08809965590005 ()


  • CAD/CAM software
NEUROWORKS 8.1.1 SOFTWARE (US)
XLTEK
104196
In Commercial Distribution

  • 00382830019231 ()


  • Electroencephalograph
DirectView Software Version 2.4
Respironics, Inc.
DirectView PC Software Application, Web - 2
In Commercial Distribution

  • 00606959028630 ()
1063558

  • Medical equipment clinical data interfacing software
BD FACSDiva™ Software
Becton, Dickinson And Company
659528
In Commercial Distribution

  • 00382906595287 ()
659528

  • Laboratory instrument/analyser application software IVD
BD FACSDiva™ Software
BECTON, DICKINSON AND COMPANY
659523
Not in Commercial Distribution

  • 00382906595232 ()
659523

  • Laboratory instrument/analyser application software IVD
Natus Elite Software - Viking
NATUS NEUROLOGY INCORPORATED
033416
In Commercial Distribution

  • 00382830061957 ()


  • Electromyograph
Natus Elite Software - Synergy
NATUS NEUROLOGY INCORPORATED
033415
In Commercial Distribution

  • 00382830061940 ()


  • Electromyograph
RemLogic 3.4.1 (ENU) Software
Embla Systems Ltd
013974
In Commercial Distribution

  • 00382830043458 ()


  • Sleep disorder interpretive software
SYNERGY REVIEW SOFTWARE CD
NATUS NEUROLOGY INCORPORATED
031K040
In Commercial Distribution

  • 00382830039475 ()


  • Electromyograph
Synergy Application Software v20.0
NATUS NEUROLOGY INCORPORATED
482-645500
In Commercial Distribution

  • 00382830038034 ()


  • Electromyograph
Synergy Software v20 CD
NATUS NEUROLOGY INCORPORATED
482-647500
In Commercial Distribution

  • 00382830038003 ()


  • Electromyograph
Review Software (Single User)
NATUS MANUFACTURING LIMITED
9033S0628
In Commercial Distribution

  • 00382830050302 ()
9033S0628

  • Electromyograph
RemLogic 4.0 Software (English)
Embla Systems Ltd
025406
In Commercial Distribution

  • 00382830048484 ()


  • Sleep disorder interpretive software
Simulset Version 3.1 Software
BECTON, DICKINSON AND COMPANY
343116
Not in Commercial Distribution

  • 00382903431168 ()
343116

  • Laboratory instrument/analyser application software IVD
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