BEUDAMED
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    MONOPOLAR SURGICAL INSTRUMENTS

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

    MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CADWELL SPIKE AND SEIZURE DETECTOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    MINIARC SINGLE-INCISION SLING

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 30, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 9, 2010

    ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·July 17, 2014

    PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014