BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    CORTI-COTE CORTISOL SOLID PHASE RADIO

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MATRIXNEURO STERILE KIT STD 4

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JEY·December 19, 2013

    TI MATRIXNEURO BURR HOLE COVER24MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JEY·October 28, 2015

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 1, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code FNL·November 9, 2012

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 18, 2010

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 23, 2013

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code JEY·August 28, 2015

    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