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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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SOFTWARE KIT 9733652 FUSION ENT - SCAND
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00643169491809 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652 FUSION ENT - EU-NW
MEDTRONIC NAVIGATION, INC.
9733652
Not in Commercial Distribution

  • 00643169491786 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652XOM FUSION ENT US
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169491762 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733937 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733937
In Commercial Distribution

  • 00643169481275 ()


  • Neurological stereotactic surgery system
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
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
Cardiac MR & CT imaging software application
Circle Cardiovascular Imaging Inc
5.6
In Commercial Distribution

  • 00882916000004 ()


  • MRI system application software
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
SOFTWARE COMP GPS 4.5 DVD PACKAGE
Widex A/S
Compass GPS 4.5
In Commercial Distribution

  • 05714880204070 ()
21027791

  • Audiometric/hearing device software
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
RETINAVUE NETWORK SOFTWARE VERSION 3.X
WELCH ALLYN, INC.
901108
In Commercial Distribution

  • 00732094223910 ()
411215

  • Retinal image analysis software
ASSY DVD CPWS SOFTWARE 1.6.6 - D
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094301212 ()
413294

  • Ophthalmic/otologic diagnostic set
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
PCH2OO Stand Alone Software, Expert Holter
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094128444 ()
704527

  • Electrocardiograph, professional, multichannel
Medical equipment clinical data interfacing software
ACCELERATED CARE PLUS CORP
100ACPLUS
In Commercial Distribution

  • 00858703006368 ()


  • Medical equipment clinical data interfacing software
prolaio Personalized Physiology Analytics Engine Software
Prolaio, Inc.
1.0
In Commercial Distribution

  • 00850071330038 ()


  • Electrocardiography monitoring system receiver
OARtrac Proprietary System Software for CDU
RADIADYNE, L.L.C.
OT-PSS
In Commercial Distribution

  • 00851546007097 ()
OT-PSS

  • MOSFET radiation therapy dosimetry system
Smartphone stethoscope software application for iPhones
Sparrow Acoustics Inc.
2.x.x
In Commercial Distribution

  • 00860011561705 ()


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

  • 00859584006164 ()


  • Tremor transducer
Kinesia Web Application/Portal 1 Software
Great Lakes Neurotechnologies Inc.
360-2005, Web Portal Software Application
In Commercial Distribution

  • 00859584006133 ()


  • Tremor transducer
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