BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    ENSPLINT TM BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607429·SKYTRON 3600 2.25" SOFTCARE PLUS

    NIAGARA SLIM-CATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VISION HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHR·May 6, 2011

    COYOTE¿ ES

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·April 26, 2013

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 23, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014