BEUDAMED
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    MODIFIED PATHFINDER SPECIMEN COLLECTION KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GOAT ANTISERUM IGM NEPHELOMHTRIC

    FDA 510(k)
    FDA Class 2 ·Immunology

    REUNION HA FRACTURE STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    SJM EPIC SUPRA STENTED PORCINE HEART VALVE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL CANADA, INC.·Product code LWR·October 8, 2010

    CONSERVE(R) TOTAL A-CLASS HEAD

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·December 12, 2012

    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