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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 - 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 - 00643169491960

SOFTWARE 9735462 DICOM LICENSE ENT
MEDTRONIC NAVIGATION, INC.
9735462
In Commercial Distribution

  • 00643169491960 ()


  • Multi-purpose stereotactic surgery system

N/A - 00643169491748

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

  • 00643169491748 ()


  • ENT stereotactic surgery system

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™ - 05415067001856

Software Upgrade Kit v.3.1
ST. JUDE MEDICAL, INC.
H700185
In Commercial Distribution

  • 05415067001856 ()
H700185

  • Cardiac mapping system application software

EP-WorkMate™ - 05415067000866

Software Upgrade Kit v.4.3.2
ST. JUDE MEDICAL, INC.
H700086
In Commercial Distribution

  • 05415067000866 ()
H700086

  • Cardiac catheterization monitoring system
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