BEUDAMED
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    BARD AND BTA TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    280SL IMAGING SYSTEM TRANVAGINAL PROBES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ASPHERE M SPEC 12/14 36 -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 15, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·January 14, 2011

    ULTRATHANE MULTIPURPOSE DRAINAGE SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQO·July 11, 2014

    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