BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFIED NOFLO I

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293227·

    PACEMAKER & CARDIAC LEAD, BIPOLAR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TempSure

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DURACON MODULAR NON-BEADED CR FEMUR ASY

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·October 13, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012

    BUDDE HALO RETRACTOR

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code GZT·April 15, 2014

    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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020