BEUDAMED
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    CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KATENA

    FDA UDI
    NURSE ASSIST, INC.·B150K870650·

    Fingertip Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALICIA MENSTRUAL CUP

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

    TOTAL ASR ACET IMP SIZE 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 13, 2014

    M2A MAGNUM MODULAR HEAD

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·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