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 9734149 UNIVERSAL ITKR S7
MEDTRONIC NAVIGATION, INC.
9734149
In Commercial Distribution

  • 00613994570352 ()


  • Orthopaedic stereotactic surgery system
SOFTWARE 9734108 StealthViz INT WIN32
MEDTRONIC NAVIGATION, INC.
9734108
In Commercial Distribution

  • 00613994556127 ()


  • Neurological stereotactic surgery system
SOFTWARE 9733686 S7 SYNERGY SPINE
MEDTRONIC NAVIGATION, INC.
9733686
In Commercial Distribution

  • 00613994422385 ()


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

  • 00613994408174 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system
A hardware for installing software.
FUJIFILM CORPORATION
DR-ID1200 GPU EX-M1 MDR E
In Commercial Distribution

  • 04547410448214 ()


  • Diagnostic x-ray digital imaging conversion system
KIT, AVEA UPGRADE GDE & SOFTWARE
VYAIRE MEDICAL, INC.
12284-PMN
Not in Commercial Distribution

  • 10190752159075 ()
12284-PMN

  • Patient monitoring system module, pulse oximetry
  • Ventilator application software
Software Application 3X version onwards
Vave Health, Inc.
VA-0303
In Commercial Distribution

  • 00850001977104 ()


  • Hand-held ultrasound imaging system, body-surface
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software
Actiware, Software CD, US Gov.
Respironics, Inc.
Actiware, Software CD, US Gov. - 6
In Commercial Distribution

  • 00606959057753 ()
1143911

  • Kinesiology ambulatory recorder
Sleepware G3 Software Package, English
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004849 ()
1082462

  • Polysomnography analyser
Neuroworks/Sleepworks 8.1.0 (International) software
XLTEK
015418
In Commercial Distribution

  • 00382830022309 ()


  • Electroencephalograph
BD FACSCanto™ System Software
Becton, Dickinson And Company
664126
In Commercial Distribution

  • 00382906641267 ()
664126

  • Laboratory analyser operation system software IVD
BD FACSCanto™ System Software
Becton, Dickinson And Company
664122
In Commercial Distribution

  • 00382906641229 ()
664122

  • Laboratory analyser operation system software IVD
BD FACSDiva™ Software v9.0
Becton, Dickinson And Company
664118
In Commercial Distribution

  • 00382906641182 ()
664118

  • Laboratory analyser operation system software IVD
BD FACSDiva™ Software v9.0
Becton, Dickinson And Company
664117
In Commercial Distribution

  • 00382906641175 ()
664117

  • Laboratory instrument/analyser application software IVD
BD FACSCanto™ System Software
Becton, Dickinson And Company
664114
In Commercial Distribution

  • 00382906641144 ()
664114

  • Laboratory analyser operation system software IVD
BD FACSCanto™ System Software
Becton, Dickinson And Company
664112
In Commercial Distribution

  • 00382906641120 ()
664112

  • Laboratory analyser operation system software IVD
BD FACSCanto System Software V2.4
BECTON, DICKINSON AND COMPANY
646600
Not in Commercial Distribution

  • 00382906466006 ()
646600

  • Laboratory instrument/analyser application software IVD
BD® HLA-B27 Software v5.1
BECTON, DICKINSON AND COMPANY
643438
Not in Commercial Distribution

  • 00382906434388 ()
643438

  • Laboratory instrument/analyser application software IVD
Synergy EDX Application Software CD
NATUS NEUROLOGY INCORPORATED
482-645900
In Commercial Distribution

  • 00382830038027 ()


  • Electromyograph
EMG v21.1.0 Application Software CD
NATUS NEUROLOGY INCORPORATED
482-651200
In Commercial Distribution

  • 00382830037969 ()


  • Electromyograph
EMG Software Upgrade to v22.4
NATUS NEUROLOGY INCORPORATED
688-628500
In Commercial Distribution

  • 00382830036160 ()


  • Electromyograph
EMG Software Update to v22.3
NATUS NEUROLOGY INCORPORATED
688-628600
In Commercial Distribution

  • 00382830036153 ()


  • Electromyograph
Natus Elite - Synergy Master Software
NATUS NEUROLOGY INCORPORATED
828-069300
In Commercial Distribution

  • 00382830035033 ()


  • Electromyograph
Natus Elite - Viking Master Software
NATUS NEUROLOGY INCORPORATED
828-069400
In Commercial Distribution

  • 00382830035026 ()


  • Electromyograph
SentrySuite Server Software Win 10
Jaeger Medical GmbH
V-577400-13
In Commercial Distribution

  • 04250892905914 ()
V-577400-13

  • Pulmonary function analysis system, adult
Natus Elite v2 Software Update
NATUS NEUROLOGY INCORPORATED
688-630000
In Commercial Distribution

  • 00382830062268 ()


  • Electromyograph
Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630100
In Commercial Distribution

  • 00382830062244 ()


  • Electromyograph
Natus Elite v2 Reader Software
NATUS NEUROLOGY INCORPORATED
828-080000
In Commercial Distribution

  • 00382830062237 ()


  • Electromyograph
Natus Elite v2 Software - Viking
NATUS NEUROLOGY INCORPORATED
828-080200
In Commercial Distribution

  • 00382830062213 ()


  • Electromyograph
Natus Elite v2 Software - Synergy
NATUS NEUROLOGY INCORPORATED
828-080100
In Commercial Distribution

  • 00382830062206 ()


  • Electromyograph
NeuroWorks/SleepWorks 10.0.1 Software (US)
XLTEK
041904
In Commercial Distribution

  • 00382830061742 ()


  • Electroencephalograph
NeuroWorks/SleepWorks 9.3.1 Software (US)
XLTEK
034879
In Commercial Distribution

  • 00382830059541 ()


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

  • 00382830050999 ()
9033S0511

  • Electromyograph
NeuroWorks/SleepWorks 9.2.1 Software (US)
XLTEK
024503
In Commercial Distribution

  • 00382830048293 ()


  • Electroencephalograph
NeuroWorks/SleepWorks 9.2.0 Software (INTL)
XLTEK
024501
In Commercial Distribution

  • 00382830048279 ()


  • Electroencephalograph
NeuroWorks/SleepWorks 9.1.1 Software (US)
XLTEK
024497
In Commercial Distribution

  • 00382830048255 ()


  • Electroencephalograph
NeuroWorks/SleepWorks 9.1.0 Software (INTL)
XLTEK
024495
In Commercial Distribution

  • 00382830048231 ()


  • Electroencephalograph
Leica Biosystems Ariol Review Software
Leica Biosystems Richmond, Inc.
23ASWREV001
In Commercial Distribution

  • 00849832003830 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
HITACHI 5.1 SOFTWARE UPGRADE PREIRUS
PENTAX OF AMERICA, INC.
HITACHI5.1UPGRD
In Commercial Distribution

  • 04961333243105 ()


  • General-purpose ultrasound imaging system
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
Ultrasound imaging system application software
ECHONOUS, INC.
P006576
In Commercial Distribution

  • 09353278000588 ()


  • Ultrasound imaging system application software
Osia™ Fitting Software 2
COCHLEAR LIMITED
P1593077
In Commercial Distribution

  • 09321502046503 ()
P1593077

  • Audiometric/hearing device software
Osia™ Fitting Software 2
COCHLEAR LIMITED
P1348428
In Commercial Distribution

  • 09321502044905 ()
P1348428

  • Audiometric/hearing device software
Osia™ Fitting Software 2
COCHLEAR LIMITED
P1341442
In Commercial Distribution

  • 09321502044899 ()
P1341442

  • Audiometric/hearing device software
Grael PSG System, no software
COMPUMEDICS LIMITED
Grael PSG
In Commercial Distribution

  • 09342451001313 ()
9028-0009-01

  • Polysomnograph
Grael LT System, no software
COMPUMEDICS LIMITED
Grael LT
In Commercial Distribution

  • 09342451001290 ()
9028-0008-01

  • Electroencephalograph
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