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    PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756693288·TURP/CYSTO PACK

    ABUSCREEN FP BENZODIAZEPHINE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RIA-GNOST FERRITIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    REALSEAL SE

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code KIF·June 26, 2014

    ZEPHYR XL SR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010

    NDEHP 3CLV YSTE MACR

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·December 28, 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