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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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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™ - 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

SeeMore ViewBladder 10 Software - 00850921007134

SeeMore ViewBladder 10 Software 2.0.03
INTERSON CORP
2.0.03 ViewBladder
In Commercial Distribution

  • 00850921007134 ()
98-3518-00

  • Extracorporeal ultrasound imaging transducer, hand-held

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

ClearPoint Array - 00850376007871

ClearPoint Array Software Version 1.2
Clearpoint Neuro, Inc.
CPA-SFW-11-12
In Commercial Distribution

  • 00850376007871 ()
CPA-SFW-11-12

  • Neurological stereotactic surgery system

ClearPoint Array - 00850376007659

ClearPoint Array Software Version 1.1
Clearpoint Neuro, Inc.
CPA-SFW-11-11
In Commercial Distribution

  • 00850376007659 ()
CPA-SFW-11-11

  • Neurological stereotactic surgery system
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