BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    FISSURE SEALER AND BONDING AGENT

    FDA 510(k)
    FDA Class 2 ·Dental

    Disposable Standard Clamp

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

    PH METER-125 (.01 PH)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE·Product code KDJ·May 5, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 15, 2012

    AXXESS PERCUTANEOUS LEAD

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 2010

    SYNFRAME RING CLAMP

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·May 10, 2019

    Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018