BEUDAMED
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    IMMUNOGLOBULINS M

    FDA 510(k)
    FDA Class 2 ·Immunology

    CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TANDEM-E -FER IMMUNOENZYMETRIC KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 16, 2014

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 19, 2010

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·December 14, 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