BEUDAMED
    7 results · 29ms · Sources: EU EUDAMED, US FDA

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    CURAY SUPPORT

    FDA 510(k)
    FDA Class 2 ·Dental

    VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EASTLYTE NA/K/CA/PH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·May 14, 2014

    UNKNOWN RIGHT HIP NECK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 8, 2013

    HS SYNERGY COMBO HOOK BLADE

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 2, 2010

    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