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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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*INACTIVE Software Upgrade, LiDCOunity v1.01 (b1765)
LIDCO LIMITED
Li10935
Not in Commercial Distribution

  • 05060110521937 ()
Li10935

  • General-purpose multi-parameter bedside monitor
Medical equipment clinical data interfacing software
ACCELERATED CARE PLUS CORP
100ACPLUS
In Commercial Distribution

  • 00858703006368 ()


  • Medical equipment clinical data interfacing software
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
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
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
SOFTWARE COMP GPS 4.5 DVD PACKAGE
Widex A/S
Compass GPS 4.5
In Commercial Distribution

  • 05714880204070 ()
21027791

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

  • 00860011561705 ()


  • Electronic acoustic stethoscope
OARtrac Proprietary System Software for CDU
RADIADYNE, L.L.C.
OT-PSS
In Commercial Distribution

  • 00851546007097 ()
OT-PSS

  • MOSFET radiation therapy dosimetry system
Cardiac MR & CT imaging software application
Circle Cardiovascular Imaging Inc
5.6
In Commercial Distribution

  • 00882916000004 ()


  • MRI system application software
Medical computer loaded with Quadsense software.
EVENTUM ORTHOPAEDICS LTD
PC001
In Commercial Distribution

  • 05065012584516 ()


  • Arthroplasty force sensor display unit
2 PCS MER3400 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MER3400
In Commercial Distribution

  • 05415067037121 ()
MER3400

  • Implantable cardiac device management application software
X EP System LiveSync Software License
ST. JUDE MEDICAL, INC.
ENSITE-LS-01
In Commercial Distribution

  • 05415067048349 ()
ENSITE-LS-01

  • Cardiac mapping system application software
prolaio Personalized Physiology Analytics Engine Software
Prolaio, Inc.
1.0
In Commercial Distribution

  • 00850071330038 ()


  • Electrocardiography monitoring system receiver
MicroTargeting Guidline 4000 5.0 Software 1x
FHC, INC.
C0217-00679
In Commercial Distribution

  • 00873263006795 ()
C0217

  • Neurophysiologic monitoring system
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