BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Immunology

    STERILE WATER FOR INHALATION FLEX BAG, USP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OsteoFab Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 6, 2013

    RESONANCE STENT SET

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FAD·February 9, 2011

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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