BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    OPTI-BRUSH

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PMT ACCUPRESSURE INFUSION SYSTEM 3601

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HOLDSTER ARM RETENTION SYSTEM

    FDA 510(k)

    P.F.C. MODULAR KNEE SYSTEM OVAL PATELLA COMPONENT

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON PROFESSIONAL, INC.·Product code HTG·February 26, 1997

    PFC CURVED TIBIAL INSERT

    FDA Adverse Event
    Injury ·JOHNSON AND JOHNSON PROFESSIONALS, INC.·Product code HSH·June 24, 1998

    AFX SYSTEM

    FDA Adverse Event
    Malfunction ·ENDOLOGIX, INC.·Product code MIH·June 10, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 11, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 10, 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