BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    MEDUS GMBH

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209116201·

    Reprocessed Electrophysiology Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RANDOX CALIBRATION SERUM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PALL TRANSFER/FREEZING BAG SET FOR PROCESSING AND FREEZING CORD BLOOD

    FDA Adverse Event
    Malfunction ·ENSATEC, S.A. DE C.V.·Product code KSR·December 23, 2009

    SLAP HAMMER M6/M10 ADAPTATOR

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS 3003895575·Product code LXH·June 6, 2014

    GENTLEWAVES

    FDA Adverse Event
    Injury ·LIGHT BIOSCIENCE LLC·Product code GEX·August 5, 2008

    ALARIS® PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·June 18, 2015

    ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 11, 2012