BEUDAMED
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    INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THE BODY BUGGY

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BIOPSY FORCEPS, ELECTRIC

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    REVO MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·February 11, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·July 24, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 10, 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