BEUDAMED
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    SPECTRUM PEDIATRIC CARDLE TABLE

    FDA 510(k)
    FDA Class 1 ·Radiology

    TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIGHTSPEED 4.0 CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 26, 2014

    PACEART SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DPS·October 31, 2012

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·August 25, 2010

    Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 30, 2014