BEUDAMED
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    ROCHE REAGENT FOR ETHANOL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909131252·REVELATION DIAMOND 858-008VF - 5 PACK

    VARIAX

    FDA UDI
    Stryker GmbH·04546540652454·VARIAX DR, AIMING BLOCK TRAY INSERT

    R2P Destination Slender Guiding Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTELLIVUE MX40 PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESORIES FOR SPACE PUMPS

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·June 25, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 2, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017