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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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Pdt-Face - 06970453270005

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

  • 06970453270005 ()


  • Red/blue light phototherapy unit

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

Archimedes Planning System - 00856571007104

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+ - 00884838028401

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 - 06430046260887

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

Optomed Aurora full set - 06430046260757

Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module.
Optomed Oy
60100635A
In Commercial Distribution

  • 06430046260757 ()


  • Multi-purpose digital medical camera

Pictor M5WEY4ES2 Volk FN - 06430046260658

Volk Pictor Plus full set
Optomed Oy
60100075A
In Commercial Distribution

  • 06430046260658 ()


  • Multi-purpose digital medical camera

Bittium Faros - 06430035220366

Device for 3-channel ECG and motion measurement, monitoring and data collection
Bittium Biosignals Oy
Faros 14d
In Commercial Distribution

  • 06430035220366 ()


  • Telemetric electrocardiographic ambulatory recorder

Bittium Faros 180 waterproof - 06430035220328

Device for 1-channel ECG and motion measurement, monitoring and data collection
Bittium Biosignals Oy
Faros 180
In Commercial Distribution

  • 06430035220328 ()


  • Telemetric electrocardiographic ambulatory recorder
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