BEUDAMED
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    ITC CONTOUR EMBOLI, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Neurology

    VIASPAN

    FDA Adverse Event
    Other ·FRESENIUS KABI AUSTRIA GMBH·Product code KDL·March 26, 2012

    VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COULTER CK-MB ISOENZYME REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GYNNIE OB-GYN STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·December 7, 2012

    INTERLINK CONTINU-FLO 4-WAY STOPCOCK EXT SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FMG·December 4, 2010

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 4, 2014

    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