BEUDAMED
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    ACA IMMUNOGLOBULIN G ANALYTICAL TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZAVATION IBF SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT

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

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 25, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    UNK

    FDA Adverse Event
    Malfunction ·UNK·Product code HNQ·August 18, 2010

    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