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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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HealthCXR - 07290018016046

No Description
NANO-X AI LTD
1.0.0
Not in Commercial Distribution

  • 07290018016046 ()


  • Radiology DICOM image processing application software

HealthICH - 07290018016039

No Description
NANO-X AI LTD
2.1.3
Not in Commercial Distribution

  • 07290018016039 ()


  • Radiology DICOM image processing application software

HealthICH - 07290018016022

No Description
NANO-X AI LTD
2.0.5
In Commercial Distribution

  • 07290018016022 ()


  • Radiology DICOM image processing application software

HealthPNX - 07290018016015

No Description
NANO-X AI LTD
1.0.6
Not in Commercial Distribution

  • 07290018016015 ()


  • Radiology DICOM image processing application software

Beaty - 07290017875002

No Description
MEDICAL FEEDBACK TECHNOLOGIES LTD
BE8789US
In Commercial Distribution

  • 17290017875009 ()
  • 07290017875002 ()


  • Cardiopulmonary resuscitation feedback device, electronic

FFRangio - 07290017855059

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

FFRangio - 07290017855028

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

Natural Cycles Application - 07350014630339

No Description
Naturalcycles Nordic AB
V5.4.0
In Commercial Distribution

  • 07350014630339 ()


  • Self-care monitoring/reporting software

Natural Cycles Application - 07350014630285

No Description
Naturalcycles Nordic AB
V5.0
In Commercial Distribution

  • 07350014630285 ()


  • Self-care monitoring/reporting software

Natural Cycles - 07350014630131

Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software
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