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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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LessRay Case, 9" C-Arm Collar
Nuvasive, Inc.
8230013
In Commercial Distribution

  • 00887517756725 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Bed Post
Nuvasive, Inc.
8230012
In Commercial Distribution

  • 00887517756718 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Array, Bed
Nuvasive, Inc.
8230011
In Commercial Distribution

  • 00887517756701 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Array, Right
Nuvasive, Inc.
8230010
In Commercial Distribution

  • 00887517756695 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Array, Left
Nuvasive, Inc.
8230009
In Commercial Distribution

  • 00887517756688 ()


  • 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
BARDY DIAGNOSTICS, INC.
B1000R7000
In Commercial Distribution

  • 20851398007010 ()


  • Electrocardiographic ambulatory recorder
No Description
BARDY DIAGNOSTICS, INC.
B1000R1400
In Commercial Distribution

  • 40851398007014 ()


  • Electrocardiographic ambulatory recorder
Red and blue light therapy device to reduce the appearance of fine lines and wrinkles and treat mild to moderate acne vulgaris.
CAPILLUS, LLC
AST-804
Not in Commercial Distribution

  • 00810045461427 ()


  • Red/blue light phototherapy unit
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