BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING

    FDA 510(k)
    FDA Class 2 ·Radiology

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 14, 2014

    ON-Q PAIN PUMP

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code MEB·January 8, 2013

    NEURAGEN NERVE GUIDE 4MM ID X 2CM LENGTH

    FDA Adverse Event
    Other ·INTEGRA LIFESCIENCES CORP·Product code JXI·November 3, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021