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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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A510 Module
Given Imaging, Inc.
800002
Not in Commercial Distribution

  • 07290101363347 ()


  • Manometric gastrointestinal motility analysis system
A500 Module
Given Imaging, Inc.
9043G0133
Not in Commercial Distribution

  • 07290101363330 ()
9043G0133

  • Manometric gastrointestinal motility analysis system
3D A300 Module
Given Imaging, Inc.
3920
In Commercial Distribution

  • 07290101362685 ()


  • Manometric gastrointestinal motility analysis system
Z A200 Module
Given Imaging, Inc.
4189
In Commercial Distribution

  • 07290101362678 ()


  • Manometric gastrointestinal motility analysis system
LessRay Monitor & Bracket, 15.6" Touch
Nuvasive, Inc.
8230007
In Commercial Distribution

  • 00887517732729 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Monitor and Bracket, 27"
Nuvasive, Inc.
8230006
In Commercial Distribution

  • 00887517732712 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Cart
Nuvasive, Inc.
8230002
In Commercial Distribution

  • 00887517732675 ()


  • Diagnostic x-ray digital imaging system workstation
The FFRangio System is a non invasive image based software device
CATHWORKS LTD
FAU04000
In Commercial Distribution

  • 17290017855056 ()
  • 07290017855059 ()
FAU04000

  • Diagnostic x-ray digital imaging system workstation
The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-‎based software ‎device that provides physicians with a quantitative analysis of ‎functional significance of a coronary ‎lesion, similar to invasive FFR (Fractional Flow ‎Reserve), and a qualitative three-dimensional model of ‎the demonstrated coronary ‎arteries, during routine PCI procedure. The FFRangio™ System performs ‎all required ‎processing and calculations based only on angiography images and hemodynamics ‎‎information that are acquired during the coronary catheterization procedure.‎
CATHWORKS LTD
FAU01000
In Commercial Distribution

  • 17290017855025 ()
  • 07290017855028 ()
FAU01000

  • Diagnostic x-ray digital imaging system workstation
No Description
Medical Measurement Systems B.V.
MPP-MT
In Commercial Distribution

  • 28717775956611 ()
  • 18717775956614 ()
  • 38717775956618 ()


  • Manometric gastrointestinal motility analysis system
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