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

  • 00643169503311 ()


  • Multi-purpose stereotactic surgery system
Software Upgrade Kit, v.2.0
ST. JUDE MEDICAL, INC.
Contact Force Module
In Commercial Distribution

  • 05415067026194 ()
H702500

  • Cardiac mapping system application software
Software Upgrade Kit, v.5.0.2
ST. JUDE MEDICAL, INC.
H702495
In Commercial Distribution

  • 05415067026101 ()
H702495

  • Cardiac mapping system application software
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software
PCS 3330 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
3330
In Commercial Distribution

  • 05414734509725 ()
3330

  • Implantable cardiac device management application software
Software Application 3X version onwards
Vave Health, Inc.
VA-0303
In Commercial Distribution

  • 00850001977104 ()


  • Hand-held ultrasound imaging system, body-surface
STarFix™ Designer Software, Version
FHC, INC.
C0265-00860
In Commercial Distribution

  • 00873263008607 ()
C0265

  • Stereotactic neuronavigation/planning system
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
Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005871 ()


  • Laboratory instrument/analyser application software IVD
Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005864 ()


  • Laboratory instrument/analyser application software IVD
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