BEUDAMED
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    DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    SCEPTOR GRAM POSITIVE MIC PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARDIO-NEC MODEL 365

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·June 19, 2014

    EON MINI IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 21, 2010

    8MM MCS TIP COVER ACCESSORY

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·December 21, 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