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

  • 05415067026101 ()
H702495

  • Cardiac mapping system application software
SOFTWARE 9735462XOM DICOM LICENSE ENT
MEDTRONIC NAVIGATION, INC.
9735462XOM
Not in Commercial Distribution

  • 00643169494916 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE KIT 9733652XOM Fusion ENT-EU-SW
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169492264 ()


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

  • 00643169492257 ()


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

  • 00643169492233 ()


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

  • 00643169492226 ()


  • ENT stereotactic surgery system
SOFTWARE 9735462 DICOM LICENSE ENT
MEDTRONIC NAVIGATION, INC.
9735462
In Commercial Distribution

  • 00643169491960 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00643169491748 ()


  • ENT stereotactic surgery system
SOFTWARE 9733686 S7 SYNERGY SPINE
MEDTRONIC NAVIGATION, INC.
9733686
In Commercial Distribution

  • 00643169480957 ()


  • Multi-purpose stereotactic surgery system
Leica Biosystems Ariol Review Software
Leica Biosystems Richmond, Inc.
23ASWREV001
In Commercial Distribution

  • 00849832003830 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Software Application 3X version onwards
Vave Health, Inc.
VA-0303
In Commercial Distribution

  • 00850001977104 ()


  • Hand-held ultrasound imaging system, body-surface
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software
SOFTWARE CD S0278-00 NOAHLINK FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169841796 ()


  • Audiometric/hearing device software
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
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
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
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-03
In Commercial Distribution

  • 05415067047854 ()
ENSITE-SW-03

  • Cardiac mapping system application software
Module Software Upgrade Single License
ST. JUDE MEDICAL, INC.
H800019
In Commercial Distribution

  • 05415067047168 ()
H800019

  • Cardiac catheterization monitoring system
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
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
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