BEUDAMED
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    MODIFIED RECTAL NOZZLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    A-GENT(TM) LIQUID GLUCOSE TRINDER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MINNESOTA SCIENTIFIC, INC. OMNI-BEAM

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

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 21, 2014

    6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LENGTH

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code MNI·December 14, 2012

    IN TOUCH ZU

    FDA Adverse Event
    Other ·STRYKER MEDICAL QUEBEC LP·Product code FNL·September 30, 2010

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013