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

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    MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE

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

    LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AUTOMIX COMPOUNDER Y - ADAPTOR SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 25, 2024

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 26, 2014

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010

    ACCU-CHEK ULTRAFLEX

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·December 7, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015