BEUDAMED
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    CATHETER BALLOON DILATOR PRESSURE GAUGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197553·AK3 PS-R Insert Trial Size 5, 11mm

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·June 25, 2014

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·January 3, 2013

    IAB: 8 FR -40 CC

    FDA Adverse Event
    Injury ·ARROW INTL., INC.·Product code DSP·November 5, 2010

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020