BEUDAMED
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    ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Pacific Blue™ anti-human CD38

    FDA UDI
    BIOLEGEND, INC.·00810034702487·URL: https://www.biolegend.com/en-us/products/p...

    RABBIT ANTIBODY TO DIGOXIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PREFILLED WATER FOR IRRIGATION USP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2014

    NEU_INS_STIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·February 27, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 2, 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