BEUDAMED
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    NO. 1552, VALVED VENTI-COMP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODEL 253-11 CYBERLITH PULSE GENERATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2014

    UNKNOWN DEPUY LCS CLASSIC STD+ 10MM INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·October 7, 2010

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 12, 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