BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    ALEXOLOK BRACKET

    FDA 510(k)
    FDA Class 1 ·Dental

    EMIT QST THEOPHYLLINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PROTET HOLDERS-BLOCKS & ROLL

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 15, 2012

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code MAF·September 14, 2010

    ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·August 14, 2019

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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