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

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    SERALYZER HEMOGLOBIN REAGENT STRIPS

    FDA 510(k)
    FDA Class 2 ·Hematology

    SURGISIS STAPLE LINE REINFORCEMENT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Death ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 20, 2014

    LINOX SMART SD 65/16

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·October 9, 2012

    POLARIS ADJUSTABLE VALVE, 10-140

    FDA Adverse Event
    Injury ·SOPHYSA·Product code JXG·August 19, 2010

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015