BEUDAMED
    7 results · 36ms · Sources: EU EUDAMED, US FDA

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    CARDIAC CATHETERIZATION PACK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES

    FDA 510(k)
    FDA Class 2 ·Dental

    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INSTRUMENT TRACKER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·May 30, 2014

    RELIANCE SYNERGY WASHER

    FDA Adverse Event
    STERIS CANADA CORPORATION·Product code LDS·November 20, 2012

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code NIQ·September 17, 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