BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Neurology

    DacryoCATH

    FDA 510(k)
    FDA Unclassified ·Unknown

    OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·January 11, 2019

    HYDROTHERMABLATOR PROCEDURE SET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MNB·November 19, 2008

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013

    Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·February 22, 2017