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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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Lumax™ TS Pro Advanced Software
Coopersurgical, Inc.
23485
In Commercial Distribution

  • 00888937013382 ()


  • Urodynamic measurement system
Zvu® Advanced GI Diagnostic Software
DIVERSATEK HEALTHCARE, INC.
ZVU-2016
In Commercial Distribution

  • 00816734022429 ()
  • B019ZVU20160 ()
ZVU-2016

  • Manometric gastrointestinal motility analysis system
Clinical Laboratory Information System application software
ASPYRA, LLC
7.3.1
In Commercial Distribution

  • B433CL0 ()
CL731

  • Clinical laboratory information system application software
360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.1
In Commercial Distribution

  • B432360CAS3110 ()


  • Robotic surgical navigation system application software
360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.0
In Commercial Distribution

  • B432360CAS3100 ()


  • Robotic surgical navigation system application software
Stand-alone software for GoCheck Kids Nokia.
Gobiquity, Inc.
Nokia 4.4.29
In Commercial Distribution

  • B430GCKNOK44290L ()


  • External ocular measurement camera
Knowledge Base Update for VITEK2 Software
BIOMERIEUX , INC.
9.03
In Commercial Distribution

  • 03573026613914 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated
ARCS ABP Analysis & Reporting Software & Dongle
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020283 ()
A10-0118-50

  • Electrocardiographic long-term ambulatory recording analyser application software
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
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 FACSCanto II System Software V2.4
BECTON, DICKINSON AND COMPANY
646601
Not in Commercial Distribution

  • 00382906466013 ()
646601

  • Laboratory instrument/analyser application software IVD
Sandman Codec Software V.2.0 CD-Elite
Embla Systems Ltd
4120082
In Commercial Distribution

  • 00382830023924 ()


  • Sleep disorder interpretive software
FACSCount CD4 Users Guide and Software
Becton, Dickinson And Company
339011
In Commercial Distribution

  • 00382903390113 ()
339011

  • Laboratory instrument/analyser application software IVD
PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSSXB
In Commercial Distribution

  • 00195278659446 ()
5933539

  • Bedside information system application software
PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSS01
In Commercial Distribution

  • 00195278341129 ()
5870857

  • Bedside information system application software
PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only
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
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
Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software
Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback 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
Sleepware G3 Software Package, Multi Lingual
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004856 ()
1082463

  • Polysomnography analyser
HL7 Software for Sleepware G3, Web
Respironics, Inc.
3.1
In Commercial Distribution

  • 00606959038967 ()
1117948

  • Clinical laboratory information system
Grael v2 System with PSG software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001771 ()
9028-0002-02

  • Polysomnograph
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