BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SIDE RAIL PADS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    i-Cut

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    THERMOPHORE AUTOMATIC HEAT PACK

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT·Product code IRT·May 24, 2014

    LIFEVEST WCD 4000 SYSTEM

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

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 15, 2015

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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