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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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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
The VUZE System (the “System”) enables users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device guidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation, fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7. The user of the VUZE System is a surgeon with the required qualifications for performing applicable spine surgeries. The System offers pre-operative surgical planning, including implant screw sizing and trajectory determination, as well as intra-operative assistance along the insertion of typical surgical tools (including tools used for placing implants) relative to rigid spinal structures.
VUZE MEDICAL LTD
VM-PK-001
In Commercial Distribution

  • 07290019776000 ()
  • 07290019776017 ()
VM-PK-001

  • 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
No Description
Beijing ADSS Development Co., Ltd.
PDT-FACE
In Commercial Distribution

  • 06970453270005 ()


  • Red/blue light phototherapy unit
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
Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue.
BRONCUS MEDICAL INC.
40009
In Commercial Distribution

  • 00856571007104 ()
40009

  • Virtual bronchoscopic navigation PACS software
SureSigns VS2+ NBP/SP02/Wireless
Philips Medical Systems Hsg
863279
In Commercial Distribution

  • 00884838028401 ()
863279

  • General-purpose multi-parameter bedside monitor
Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module.
Optomed Oy
60101813A
In Commercial Distribution

  • 06430046260887 ()


  • Multi-purpose digital medical camera
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