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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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NA - 00643169841796

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

  • 00643169841796 ()


  • Audiometric/hearing device software

Synergy® Spine & Trauma - 00643169480957

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

  • 00643169480957 ()


  • Multi-purpose stereotactic surgery system

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

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
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