BEUDAMED
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    SHERWOOD WATER TRAP

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Spectralis HRA+OCT and variants with High Magnification Module

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFICATION TO: INJECTABLE MIMIX

    FDA 510(k)
    FDA Class 2 ·Neurology

    REALSEAL

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code KIF·May 15, 2014

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MMI·August 24, 2010

    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