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

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    RAPIDTEST-HCG (TM)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    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

    GEO-TIBIAL RETAINER ROTATIONAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SonoSite SII Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAYFIELD 2000 SKULL CLAMP

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORP. (INTEGRA-OHIO)·Product code HBL·October 20, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 7, 2014

    MATRIX POLYAXIAL SCREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·December 21, 2012

    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