BEUDAMED
    9 results · 35ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    P-S MEDICAL CSF-SIPHON CONTROL DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    FEMEX

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

    ALEXIS WOUND RETRACTOR

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

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 9, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 20, 2014

    ASR ACETABULAR IMPLANT 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·December 10, 2012

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·July 26, 2020

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    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