BEUDAMED
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    VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BAUMAN CPR/RESPIRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DUPONT ALCOHOL CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS, INC.·Product code LNR·June 19, 2014

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·February 15, 2013

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - FREMONT·Product code DQO·January 19, 2011

    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