BEUDAMED
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    BETASTAR 1131.02 MOBILE OPERATING TABLE

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

    BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·December 14, 2010

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·January 17, 2013

    UNKNOWN DEPUY PINNACLE METAL LINER

    FDA Adverse Event
    DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·July 10, 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