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

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    K883239

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 24, 2009

    CAPD DISP DISCONNECT, UV FLASH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code KDJ·May 23, 2008

    CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS

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

    CoreLink F3D™ Lateral System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOFTGOOD PRODUCTS AND SPLINTS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE

    FDA Adverse Event
    Malfunction ·XOMED MFG JACKSONVILLE·Product code ETN·December 21, 2012

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code LQC·October 26, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 7, 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