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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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N/A - 00643169363847

SOFTWARE 9735345 INSTALL MEDIA TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735345
In Commercial Distribution

  • 00643169363847 ()


  • Multi-purpose stereotactic surgery system

CareLink® - 00643169175341

SOFTWARE MMT-7335 V3.2 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00643169175341 ()


  • Patient health record information system application software

CareLink® - 00643169288409

SOFTWARE MMT-7335 V3.4 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
In Commercial Distribution

  • 00643169288409 ()


  • Patient health record information system application software

N/A - 00643169491823

SOFTWARE KIT 9733652 FUSION ENT - EU-SE
MEDTRONIC NAVIGATION, INC.
9733652
Not in Commercial Distribution

  • 00643169491823 ()


  • ENT stereotactic surgery system

N/A - 00643169491816

SOFTWARE KIT 9733652 FUSION ENT - EU-E
MEDTRONIC NAVIGATION, INC.
9733652
Not in Commercial Distribution

  • 00643169491816 ()


  • ENT stereotactic surgery system

N/A - 00643169491809

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

  • 00643169491809 ()


  • ENT stereotactic surgery system

N/A - 00643169491793

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

  • 00643169491793 ()


  • ENT stereotactic surgery system

N/A - 00643169491786

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

  • 00643169491786 ()


  • ENT stereotactic surgery system

N/A - 00643169491779

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

  • 00643169491779 ()


  • ENT stereotactic surgery system

N/A - 00643169491762

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

  • 00643169491762 ()


  • ENT stereotactic surgery system

Synergy® - 00643169481275

SOFTWARE KIT 9733937 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733937
In Commercial Distribution

  • 00643169481275 ()


  • Neurological stereotactic surgery system

N/A - 00643169492240

SOFTWARE KIT 9733652XOM Fusion ENT -EU-E
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169492240 ()


  • ENT stereotactic surgery system

LiDCO - 05060110522941

* INACTIVE Software Upgrade, LiDCOunity v1.01 (b1941)
LIDCO LIMITED
Li11177
Not in Commercial Distribution

  • 05060110522941 ()
Li11177

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522781

* INACTIVE Software Upgrade, LiDCOunity v2.02 (b231)
LIDCO LIMITED
LI11171
Not in Commercial Distribution

  • 05060110522781 ()
LI11171

  • General-purpose multi-parameter bedside monitor

LiDCO - 05060110522767

* INACTIVE Software Upgrade, LiDCOunity v2.03 (b301)
LIDCO LIMITED
Li11178
Not in Commercial Distribution

  • 05060110522767 ()
Li11178

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522606

* INACTIVE Software Upgrade, LiDCOunity v1.01 (b1935)
LIDCO LIMITED
Li11150
Not in Commercial Distribution

  • 05060110522606 ()
Li11150

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522378

Licence, Software, LiDCOrapid (Rapid, BIS, Ext)
LIDCO LIMITED
Li11080
In Commercial Distribution

  • 05060110522378 ()
Li11080

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522354

Licence, Software, LiDCOplus (Plus, Li, Ext)
LIDCO LIMITED
Li11078
In Commercial Distribution

  • 05060110522354 ()
Li11078

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522187

* INACTIVE Software Upgrade, LiDCOrapid v2.06 (b1326)
LIDCO LIMITED
Li11056
Not in Commercial Distribution

  • 05060110522187 ()
Li11056

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522125

* INACTIVE Software Upgrade, LiDCOrapid v2.06 (b1324)
LIDCO LIMITED
Li10979
Not in Commercial Distribution

  • 05060110522125 ()
Li10979

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110521937

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

  • 05060110521937 ()
Li10935

  • General-purpose multi-parameter bedside monitor

ACPlus Platform - 00858703006368

Medical equipment clinical data interfacing software
ACCELERATED CARE PLUS CORP
100ACPLUS
In Commercial Distribution

  • 00858703006368 ()


  • Medical equipment clinical data interfacing software

WayPoint™ Planner - 00873263004371

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

  • 00873263004371 ()
66-WP-PL

  • Neurological stereotactic surgery system

WIDEX - 05714880256772

SOFTWARE COMP GPS 4.8 USB PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256772 ()
21041975

  • Audiometric/hearing device software

WIDEX - 05714880256765

SOFTWARE COMP GPS 4.8 DVD PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256765 ()
21041974

  • Audiometric/hearing device software

Kinesia - 00859584006164

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

  • 00859584006164 ()


  • Tremor transducer

Kinesia - 00859584006133

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

  • 00859584006133 ()


  • Tremor transducer

Welch Allyn, Inc. - 00732094301212

ASSY DVD CPWS SOFTWARE 1.6.6 - D
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094301212 ()
413294

  • Ophthalmic/otologic diagnostic set

Welch Allyn, Inc. - 00732094223910

RETINAVUE NETWORK SOFTWARE VERSION 3.X
WELCH ALLYN, INC.
901108
In Commercial Distribution

  • 00732094223910 ()
411215

  • Retinal image analysis software

OTHERS - 05714880204070

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

  • 05714880204070 ()
21027791

  • Audiometric/hearing device software

WIDEX - 05714880239140

SOFTWARE COMP GPS 4.7 USB PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239140 ()
21038004

  • Audiometric/hearing device software

WIDEX - 05714880239133

SOFTWARE COMP GPS 4.7 DVD PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239133 ()
21038003

  • Audiometric/hearing device software

Stethophone - 00860011561705

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

  • 00860011561705 ()


  • Electronic acoustic stethoscope

OARtrac - 00851546007097

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

  • 00851546007097 ()
OT-PSS

  • MOSFET radiation therapy dosimetry system

cvi42 - 00882916000004

Cardiac MR & CT imaging software application
Circle Cardiovascular Imaging Inc
5.6
In Commercial Distribution

  • 00882916000004 ()


  • MRI system application software

Panel PC - 05065012584516

Medical computer loaded with Quadsense software.
EVENTUM ORTHOPAEDICS LTD
PC001
In Commercial Distribution

  • 05065012584516 ()


  • Arthroplasty force sensor display unit

Merlin™ - 05415067037121

2 PCS MER3400 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MER3400
In Commercial Distribution

  • 05415067037121 ()
MER3400

  • Implantable cardiac device management application software

EnSite™ - 05415067048349

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 (PPA) - 00850071330038

prolaio Personalized Physiology Analytics Engine Software
Prolaio, Inc.
1.0
In Commercial Distribution

  • 00850071330038 ()


  • Electrocardiography monitoring system receiver

Guideline 4000™ 5.0 - 00873263006795

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

  • 00873263006795 ()
C0217

  • Neurophysiologic monitoring system

ImageXL - 00861787000306

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

3CPM Company, Inc. - 00864359000285

3CPM EGGSAS Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000285 ()


  • Myoelectric gastrointestinal motility analysis system

3CPM Company, Inc. - 00864359000247

3CPM EGGSAS Research Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000247 ()


  • Myoelectric gastrointestinal motility analysis system

Welch Allyn, Inc. - 00732094043488

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

  • 00732094043488 ()
SW-CCW-LIC

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094041033

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

  • 00732094041033 ()
UPDT-WACPW-CD

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094128444

PCH2OO Stand Alone Software, Expert Holter
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094128444 ()
704527

  • Electrocardiograph, professional, multichannel

Ultra Transfusion Medicine - 05060508820031

Software, blood bank, stand alone product
CIRDAN IMAGING LIMITED
4.1
In Commercial Distribution

  • 05060508820031 ()


  • Blood bank information system application software

Axon - 09413000107500

Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system

VolparaDensity - 09421904268166

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 - 09421904268029

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
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