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

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    Filters Regulation: Us FDA ×

    ABBOTT RSV EIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZipE Knotless Tissue Repair and Attachment Devices

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIVA XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    ACTIVA

    FDA Adverse Event
    Malfunction ·NEURO - VILLALBA·Product code MHY·December 10, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 23, 2015

    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