BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    DePuy Reclaim Monobloc Revision Femoral Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SAFESTEP 20G X 3/4 STRAIGHT

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code FPA·May 18, 2009

    EZ-BLOCKER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 3, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 17, 2011

    UNK SCAFFOLD

    FDA Adverse Event
    Injury ·ALLERGAN·Product code FTL·July 9, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024