BEUDAMED
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    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500

    FDA 510(k)
    FDA Class 2 ·Hematology

    XPECT FLU A & B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MINT Product Family

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

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWY·March 7, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    CONCERTO CRT-D DR AT

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·February 15, 2011

    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