BEUDAMED
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    LYSTA HYGIENIST III SCALER

    FDA 510(k)
    FDA Class 2 ·Dental

    CEDIA (TM) CORTISOL ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 9, 2013

    LAMITRODE 44C LEAD, 60CM LENGTH

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 1, 2014

    CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code MXZ·August 2, 2018

    VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable, hand-held, battery-operated device intended to stimulate motor nerves exposed during surgery for the purpose of identification or location.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code ETN·November 21, 2008

    NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code ETN·June 28, 2016

    REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code ETN·March 4, 2013