BEUDAMED
    10 results · 57ms · Sources: EU EUDAMED, US FDA

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    MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator

    FDA Recall
    Terminated ·Fujifilm Medical System USA, Inc.·Product code MUE·June 29, 2012

    Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344

    FDA Recall
    Terminated ·Fujifilm Medical System USA, Inc.·Product code MQB·September 30, 2004

    Fuji Flash IIP and CR-IR346CL Consoles

    FDA Recall
    Terminated ·Fujifilm Medical System USA, Inc.·Product code MQB·May 5, 2004

    Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS

    FDA Recall
    Terminated ·Fujifilm Medical System USA, Inc.·Product code LLZ·February 3, 2006

    Synapse Version 2.2.1 and 2.3.1 software

    FDA Recall
    Terminated ·Fujifilm Medical System USA, Inc.·Product code LLZ·May 12, 2003

    Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·August 31, 2015

    MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical System USA, Inc.·May 28, 2014

    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015

    Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015

    Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.

    FDA Recall
    Terminated ·Fujinon Inc·Product code FDS·July 31, 2013