BEUDAMED
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    REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES

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

    DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BARTELS RUBELLA IGG EIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MULTI-LUMEN/PSI SET

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code FOZ·January 17, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 14, 2010

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·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