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

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    STAT/PB REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AMPCO KIDNEY DIALYSIS TRAY

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

    Alteon® HA Femoral Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INNOVA?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIP·June 2, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 26, 2012

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·June 15, 2015

    PIPELINE

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 12, 2022

    PIPELINE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 24, 2022

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018