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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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Merlin™ - 05414734509725

PCS 3330 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
3330
In Commercial Distribution

  • 05414734509725 ()
3330

  • Implantable cardiac device management application software

LiDCO - 05060110523016

Software Upgrade, LiDCOunity v1.01 (b1943)
LIDCO LIMITED
Li11238
In Commercial Distribution

  • 05060110523016 ()
Li11238

  • General-purpose multi-parameter bedside monitor

LiDCO - 05060110522934

Software Upgrade, LiDCOunity v2.03 (b318)
LIDCO LIMITED
Li11197
In Commercial Distribution

  • 05060110522934 ()
Li11197

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522613

Software Upgrade, LiDCOrapid v2.06 (b1328)
LIDCO LIMITED
Li11151
In Commercial Distribution

  • 05060110522613 ()
Li11151

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522156

Software Upgrade, LiDCOunity v1.01 (b1935)
LIDCO LIMITED
Li11150
In Commercial Distribution

  • 05060110522156 ()
Li11150

  • General-purpose multi-parameter bedside monitor

NA - 00643169648975

SOFTWARE CD S0278-00 GRAV FIT
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169648975 ()


  • Audiometric/hearing device software

NA - 00643169693616

SOFTWARE 9735638 FUSION COMPACT ENT
MEDTRONIC NAVIGATION, INC.
9735638
In Commercial Distribution

  • 00643169693616 ()


  • ENT stereotactic surgery system

NA - 00643169671553

SOFTWARE CD S0278-00 NOAH FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169671553 ()


  • Audiometric/hearing device software

NA - 00643169841796

SOFTWARE CD S0278-00 NOAHLINK FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169841796 ()


  • Audiometric/hearing device software

N/A - 00613994753106

SOFTWARE 9734587 3D FLUORO CALIBRATION
MEDTRONIC NAVIGATION, INC.
9734587
In Commercial Distribution

  • 00613994753106 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994422385

SOFTWARE 9733686 S7 SYNERGY SPINE
MEDTRONIC NAVIGATION, INC.
9733686
In Commercial Distribution

  • 00613994422385 ()


  • Multi-purpose stereotactic surgery system

Synergy® - 00613994408174

SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00613994408174 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994377517

SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system

N/A - 00613994680891

SOFTWARE 9734400XOM STEALTHMERGE ENT PG
MEDTRONIC NAVIGATION, INC.
9734400XOM
In Commercial Distribution

  • 00613994680891 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994570369

SOFTWARE 9734150 UNIVERSAL ITHR S7
MEDTRONIC NAVIGATION, INC.
9734150
In Commercial Distribution

  • 00613994570369 ()


  • Orthopaedic stereotactic surgery system

NA - 00613994570352

SOFTWARE 9734149 UNIVERSAL ITKR S7
MEDTRONIC NAVIGATION, INC.
9734149
In Commercial Distribution

  • 00613994570352 ()


  • Orthopaedic stereotactic surgery system

N/A - 00613994556127

SOFTWARE 9734108 StealthViz INT WIN32
MEDTRONIC NAVIGATION, INC.
9734108
In Commercial Distribution

  • 00613994556127 ()


  • Neurological stereotactic surgery system

N/A - 00613994467089

SOFTWARE 9733808 DICOM Q/R
MEDTRONIC NAVIGATION, INC.
9733808
In Commercial Distribution

  • 00613994467089 ()


  • Multi-purpose stereotactic surgery system

Synergy®Cranial - 00643169503311

SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00643169503311 ()


  • Multi-purpose stereotactic surgery system

N/A - 00643169494916

SOFTWARE 9735462XOM DICOM LICENSE ENT
MEDTRONIC NAVIGATION, INC.
9735462XOM
Not in Commercial Distribution

  • 00643169494916 ()


  • Multi-purpose stereotactic surgery system

N/A - 00643169492264

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

  • 00643169492264 ()


  • ENT stereotactic surgery system

N/A - 00643169492257

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

  • 00643169492257 ()


  • ENT stereotactic surgery system

N/A - 00643169492233

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

  • 00643169492233 ()


  • ENT stereotactic surgery system

N/A - 00643169492226

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

  • 00643169492226 ()


  • ENT stereotactic surgery system

N/A - 00643169491748

SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00643169491748 ()


  • ENT stereotactic surgery system

N/A - 00643169272583

SOFTWARE KIT 9735235 MICROSCOPE ROBOTICS
MEDTRONIC NAVIGATION, INC.
9735235
In Commercial Distribution

  • 00643169272583 ()


  • Neurological stereotactic surgery system

Not Applicable - 10195278901764

Software Pristina 9 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.9
In Commercial Distribution

  • 10195278901764 ()


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

EnSite™ Verismo™ - 05415067026293

Software Upgrade Kit, v.2.0.1
ST. JUDE MEDICAL, INC.
H702504
In Commercial Distribution

  • 05415067026293 ()
H702504

  • Cardiac mapping system application software

EnSite™ Fusion™ - 05415067026224

Software Upgrade Kit, v.7.1
ST. JUDE MEDICAL, INC.
H702506
In Commercial Distribution

  • 05415067026224 ()
H702506

  • Cardiac mapping system application software

EnSite™ - 05415067026194

Software Upgrade Kit, v.2.0
ST. JUDE MEDICAL, INC.
Contact Force Module
In Commercial Distribution

  • 05415067026194 ()
H702500

  • Cardiac mapping system application software

EnSite™ Velocity™ - 05415067026101

Software Upgrade Kit, v.5.0.2
ST. JUDE MEDICAL, INC.
H702495
In Commercial Distribution

  • 05415067026101 ()
H702495

  • Cardiac mapping system application software

EnSite™ - 05415067050014

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.0.2
In Commercial Distribution

  • 05415067050014 ()
ENSITE-SW-3.0.2

  • Cardiac mapping system application software

EnSite™ - 05415067049704

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1
In Commercial Distribution

  • 05415067049704 ()
ENSITE-SW-3.1

  • Cardiac mapping system application software

EnSite™ - 05415067047854

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-03
In Commercial Distribution

  • 05415067047854 ()
ENSITE-SW-03

  • Cardiac mapping system application software

WorkMate™ Unity™ - 05415067047168

Module Software Upgrade Single License
ST. JUDE MEDICAL, INC.
H800019
In Commercial Distribution

  • 05415067047168 ()
H800019

  • Cardiac catheterization monitoring system

EnSite™ - 05415067046703

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-2.0.1
In Commercial Distribution

  • 05415067046703 ()
ENSITE-SW-2.0.1

  • Cardiac mapping system application software

EnSite™ - 05415067046215

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1.2
In Commercial Distribution

  • 05415067046215 ()
ENSITE-SW-1.1.2

  • Cardiac mapping system application software

Ultreon™ - 05415067045331

1.0 Software Update vF.0.1
ST. JUDE MEDICAL, INC.
1015191
In Commercial Distribution

  • 05415067045331 ()
1015191

  • Coronary optical coherence tomography system

EnSite™ - 05415067040770

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1.1
In Commercial Distribution

  • 05415067040770 ()
ENSITE-SW-1.1.1

  • Cardiac mapping system application software

EnSite™ - 05415067053121

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1.1
In Commercial Distribution

  • 05415067053121 ()
ENSITE-SW-3.1.1

  • Cardiac mapping system application software
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