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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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FACSCanto - 00382906641229

BD FACSCanto™ System Software
Becton, Dickinson And Company
664122
In Commercial Distribution

  • 00382906641229 ()
664122

  • Laboratory analyser operation system software IVD

BD FACSDiva - 00382906641182

BD FACSDiva™ Software v9.0
Becton, Dickinson And Company
664118
In Commercial Distribution

  • 00382906641182 ()
664118

  • Laboratory analyser operation system software IVD

BD FACSDiva - 00382906641175

BD FACSDiva™ Software v9.0
Becton, Dickinson And Company
664117
In Commercial Distribution

  • 00382906641175 ()
664117

  • Laboratory instrument/analyser application software IVD

FACSCanto - 00382906641144

BD FACSCanto™ System Software
Becton, Dickinson And Company
664114
In Commercial Distribution

  • 00382906641144 ()
664114

  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641120

BD FACSCanto™ System Software
Becton, Dickinson And Company
664112
In Commercial Distribution

  • 00382906641120 ()
664112

  • Laboratory analyser operation system software IVD

BD FACSCanto™ - 00382906466006

BD FACSCanto System Software V2.4
BECTON, DICKINSON AND COMPANY
646600
Not in Commercial Distribution

  • 00382906466006 ()
646600

  • Laboratory instrument/analyser application software IVD

N/A - 00382906434388

BD® HLA-B27 Software v5.1
BECTON, DICKINSON AND COMPANY
643438
Not in Commercial Distribution

  • 00382906434388 ()
643438

  • Laboratory instrument/analyser application software IVD

Natus - 00382830022309

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

  • 00382830022309 ()


  • Electroencephalograph

VistaScan™ - 00850017464001

VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software

Nihon Kohden Life Scope G7 Bedside Monitoring System - 04931921006689

Software Kit (for CU-171R, CU-172R)
NIHON KOHDEN CORPORATION
QS-127P
In Commercial Distribution

  • 04931921006689 ()
QS-127P

  • General-purpose multi-parameter bedside monitor

Nihon Kohden Life Scope G5 Bedside Monitoring System - 04931921002179

Software Kit (for CU-151R, CU-152R)
NIHON KOHDEN CORPORATION
QS-116P
In Commercial Distribution

  • 04931921002179 ()
QS-116P

  • General-purpose multi-parameter bedside monitor

N/A - 00613994570369

SOFTWARE 9734150 UNIVERSAL ITHR S7
MEDTRONIC NAVIGATION, INC.
9734150
In Commercial Distribution

  • 00613994570369 ()


  • Orthopaedic stereotactic surgery system

NA - 00613994570352

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

  • 00613994570352 ()


  • Orthopaedic stereotactic surgery system

N/A - 00613994556127

SOFTWARE 9734108 StealthViz INT WIN32
MEDTRONIC NAVIGATION, INC.
9734108
In Commercial Distribution

  • 00613994556127 ()


  • Neurological stereotactic surgery system

StealthStation® iNav w/ AxiEM™ TechNology - 00613994231383

SOFTWARE 9733260 AXIEM CRANIAL INAV
MEDTRONIC NAVIGATION, INC.
9733260
In Commercial Distribution

  • 00613994231383 ()


  • Multi-purpose stereotactic surgery system

AVEA - 10190752159075

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

N/A - 00613994467089

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

  • 00613994467089 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994680891

SOFTWARE 9734400XOM STEALTHMERGE ENT PG
MEDTRONIC NAVIGATION, INC.
9734400XOM
In Commercial Distribution

  • 00613994680891 ()


  • Multi-purpose stereotactic surgery system

ORTHOMAP - 04546540717450

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 - 04546540717443

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

N/A - 04961333229864

Nueroscience for Human Communication, Software
PENTAX OF AMERICA, INC.
5155
In Commercial Distribution

  • 04961333229864 ()


  • Electroglottograph

N/A - 04961333229826

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

  • 04961333229826 ()


  • Electroglottograph

MDVP - 04961333229741

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

  • 04961333229741 ()


  • Electroglottograph

PREIRUS - 04961333243105

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 - 00849832003830

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

  • 00849832003830 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Vave - 00850001977104

Software Application 3X version onwards
Vave Health, Inc.
VA-0303
In Commercial Distribution

  • 00850001977104 ()


  • Hand-held ultrasound imaging system, body-surface

Actiware - 00606959057753

Actiware, Software CD, US Gov.
Respironics, Inc.
Actiware, Software CD, US Gov. - 6
In Commercial Distribution

  • 00606959057753 ()
1143911

  • Kinesiology ambulatory recorder

NA - 04931921113080

SOFTWARE, EVENT POTENTIAL FOR MEB-2300
NIHON KOHDEN CORPORATION
QP-260BK
In Commercial Distribution

  • 04931921113080 ()
QP-260BK

  • Evoked-potential graphic recording system

N/A - 00613994422385

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

  • 00613994422385 ()


  • Multi-purpose stereotactic surgery system

Synergy® - 00613994408174

SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00613994408174 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994377517

SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system

EX-M1 - 04547410448214

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

N/A - 00613994753106

SOFTWARE 9734587 3D FLUORO CALIBRATION
MEDTRONIC NAVIGATION, INC.
9734587
In Commercial Distribution

  • 00613994753106 ()


  • Multi-purpose stereotactic surgery system

Distender II Barostat - 00627843670957

Protocol Plus Software version 10.3
G&J Electronics Inc
PPS-10.3
In Commercial Distribution

  • 00627843670957 ()


  • Gastrointestinal barostat

Distender II Barostat - 00627843670940

Protocol Plus Version 9.8 software
G&J Electronics Inc
PPS-9.8
In Commercial Distribution

  • 00627843670940 ()


  • Gastrointestinal barostat

N/A - 07613327542868

Ortho Guidance Versatile Hip Software
Stryker Leibinger GmbH & Co. KG
6007-700-000
In Commercial Distribution

  • 07613327542868 ()
6007-700-000

  • Robotic surgical navigation system application software

N/A - 07613327542332

Ortho Guidance Express Knee Software
Stryker Leibinger GmbH & Co. KG
6003-710-000
In Commercial Distribution

  • 07613327542332 ()
6003-710-000

  • Robotic surgical navigation system application software

N/A - 07613327541809

Ortho Guidance Precision Knee Software
Stryker Leibinger GmbH & Co. KG
6003-700-000
In Commercial Distribution

  • 07613327541809 ()
6003-700-000

  • Robotic surgical navigation system application software

Unitron - 07613389303292

AuraFit Fitting Software v4.x
Unitron Hearing Division
058-5236
In Commercial Distribution

  • 07613389303292 ()
058-5236

  • Audiometric/hearing device software

Unitron - 07613389303285

TrueFit Fitting Software v4.x
Unitron Hearing Division
058-5235
In Commercial Distribution

  • 07613389303285 ()
058-5235

  • Audiometric/hearing device software
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