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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CUSTOM SOUND SUITE 4.1 SOFTWARE - CAM
COCHLEAR LIMITED
Z494179
In Commercial Distribution

  • 09321502029469 ()
Z494179

  • Audiometric/hearing device software
VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.1
In Commercial Distribution

  • 09421904268166 ()


  • Radiology DICOM image processing application software
VolparaDensity 3.2 (Volpara Imaging Software 1.5.2)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.2
Not in Commercial Distribution

  • 09421904268029 ()


  • Radiology DICOM image processing application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498313020 ()
31302

  • Ventilator application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498000722 ()
31302

  • Ventilator application software
Applied Speech Science for Dysarthrias, Software
PENTAX OF AMERICA, INC.
5153
Not in Commercial Distribution

  • 04961333229840 ()


  • Electroglottograph
Respiration, Phonation and Prosody Simulation, Software
PENTAX OF AMERICA, INC.
5152
Not in Commercial Distribution

  • 04961333229833 ()


  • Electroglottograph
Stride Device Manager Application software kit
Siemens Healthcare Diagnostics Inc.
10714617
In Commercial Distribution

  • 00630414001975 ()
10714617

  • Medical equipment clinical data interfacing software
Offload Software for the BioSticker System.
BIOINTELLISENSE, INC.
SWDT10001-1.1.1
In Commercial Distribution

  • 00850005949046 ()


  • Electrocardiography telemetric monitoring system transmitter
3CPM EGGSAS Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000285 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Research Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000247 ()


  • Myoelectric gastrointestinal motility analysis system
IMAGEXL XRAY SOFTWARE VERSION 4 BASE
PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
4
In Commercial Distribution

  • 00861787000306 ()


  • General-purpose dental x-ray system application software
Kinesia Web Application/Portal 1 Software
Great Lakes Neurotechnologies Inc.
360-2005, Web Portal Software Application
In Commercial Distribution

  • 00859584006133 ()


  • Tremor transducer
Kinesia Web Application/Portal 2 Software
Great Lakes Neurotechnologies Inc.
360-2011, Kinesia Web App/Portal 2
In Commercial Distribution

  • 00859584006164 ()


  • Tremor transducer
SOFTWARE COMP GPS 4.5 DVD PACKAGE
Widex A/S
Compass GPS 4.5
In Commercial Distribution

  • 05714880204070 ()
21027791

  • Audiometric/hearing device software
Smartphone stethoscope software application for iPhones
Sparrow Acoustics Inc.
2.x.x
In Commercial Distribution

  • 00860011561705 ()


  • Electronic acoustic stethoscope
MicroTargeting Guidline 4000 5.0 Software 1x
FHC, INC.
C0217-00679
In Commercial Distribution

  • 00873263006795 ()
C0217

  • Neurophysiologic monitoring system
microTargeting WayPoint Planner Software, single license
FHC, INC.
66-WP-PL-00437
In Commercial Distribution

  • 00873263004371 ()
66-WP-PL

  • Neurological stereotactic surgery system
SOFTWARE COMP GPS 4.8 USB PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256772 ()
21041975

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.8 DVD PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256765 ()
21041974

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.7 USB PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239140 ()
21038004

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.7 DVD PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239133 ()
21038003

  • Audiometric/hearing device software
ASSY DVD CPWS SOFTWARE 1.6.6 - D
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094301212 ()
413294

  • Ophthalmic/otologic diagnostic set
RETINAVUE NETWORK SOFTWARE VERSION 3.X
WELCH ALLYN, INC.
901108
In Commercial Distribution

  • 00732094223910 ()
411215

  • Retinal image analysis software
PCH2OO Stand Alone Software, Expert Holter
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094128444 ()
704527

  • Electrocardiograph, professional, multichannel
CCW Software Viewing License (per computer)
WELCH ALLYN, INC.
901047
In Commercial Distribution

  • 00732094043488 ()
SW-CCW-LIC

  • Electrocardiograph, professional, multichannel
CardioPerfect Workstation Software Update (latest version)
WELCH ALLYN, INC.
901047
In Commercial Distribution

  • 00732094041033 ()
UPDT-WACPW-CD

  • Electrocardiograph, professional, multichannel
Cardiac MR & CT imaging software application
Circle Cardiovascular Imaging Inc
5.6
In Commercial Distribution

  • 00882916000004 ()


  • MRI system application software
Sandman Codec Software V.2.0 CD-Elite
Embla Systems Ltd
4120082
In Commercial Distribution

  • 00382830023924 ()


  • Sleep disorder interpretive software
BD FACSCanto™ II System Software
Becton, Dickinson And Company
664124
In Commercial Distribution

  • 00382906641243 ()
664124

  • Laboratory analyser operation system software IVD
BD FACSCanto™ Clinical Software v4.0.1
Becton, Dickinson And Company
664119
In Commercial Distribution

  • 00382906641199 ()
664119

  • Laboratory analyser operation system software IVD
BD FACSCanto™ II System Software
Becton, Dickinson And Company
664110
In Commercial Distribution

  • 00382906641106 ()
664110

  • Laboratory analyser operation system software IVD
BD BBL Crystal™ MIND Software
BECTON, DICKINSON AND COMPANY
441010
Not in Commercial Distribution

  • 00382904410100 ()
441010

  • Human infectome analysis interpretive software IVD
BD FACSCanto II System Software V2.4
BECTON, DICKINSON AND COMPANY
646601
Not in Commercial Distribution

  • 00382906466013 ()
646601

  • Laboratory instrument/analyser application software IVD
Natus Elite Software - Synergy & Viking Combo
NATUS NEUROLOGY INCORPORATED
033417
In Commercial Distribution

  • 00382830061964 ()


  • Electromyograph
Review Software (10+ Users Floating License)
NATUS MANUFACTURING LIMITED
9033S0731
In Commercial Distribution

  • 00382830050340 ()
9033S0731

  • Electromyograph
Review Software (10 Users Floating License)
NATUS MANUFACTURING LIMITED
9033S0721
In Commercial Distribution

  • 00382830050333 ()
9033S0721

  • Electromyograph
Review Software (5 Users Floating License)
NATUS MANUFACTURING LIMITED
9033S0711
In Commercial Distribution

  • 00382830050326 ()
9033S0711

  • Electromyograph
FACSCount CD4 Users Guide and Software
Becton, Dickinson And Company
339011
In Commercial Distribution

  • 00382903390113 ()
339011

  • Laboratory instrument/analyser application software IVD
Sleepware G3 Software Package, Multi Lingual
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004856 ()
1082463

  • Polysomnography analyser
SOFTWARE MMT-7335 V2.3 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00613994749208 ()


  • Patient health record information system application software
SOFTWARE MMT-7335 CD-ROM CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00613994342805 ()


  • Patient health record information system application software
SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD
MEDTRONIC XOMED, INC.
8263005
In Commercial Distribution

  • 00613994161635 ()


  • Nerve-locating system
Knee Software Package, ART 2.0.1 Add-on
Omni Life Science, Inc.
NS-27007
In Commercial Distribution

  • 00841690194538 ()
NS-27007

  • Instrument tray, reusable
Knee Software Package, ART 2.1 Add-on
Omni Life Science, Inc.
NS-27008
In Commercial Distribution

  • 00841690194521 ()
NS-27008

  • Instrument tray, reusable
Knee Software Package, ART 2.2 Add-on
Omni Life Science, Inc.
NS-27009
In Commercial Distribution

  • 00841690194514 ()
NS-27009

  • Instrument tray, reusable
Knee Software Package, ART 2.3 Add-on
Omni Life Science, Inc.
NS-27010
In Commercial Distribution

  • 00841690194507 ()
NS-27010

  • Instrument tray, reusable
Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software
HL7 Software for Sleepware G3, Web
Respironics, Inc.
3.1
In Commercial Distribution

  • 00606959038967 ()
1117948

  • Clinical laboratory information system
Software Pristina ME 9.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA ME 9.2
In Commercial Distribution

  • 00195278719812 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
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