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

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    COBAS REAGENTS PHENOBARBITAL & PHENOBAR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NOSITE UV INTERIM SPECTACLES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MULTI-LUMEN INTRAVENOUS INFUSION CATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN HIP ACETABULAR LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 2, 2014

    LIFEVEST WCD 4000 SYSTEM

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

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code NIP·September 10, 2010

    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