BEUDAMED
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    BLOOD SPECIMEN COLLECTION DEVICES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NuVasive CoRoent Small Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T2 SCEPTOR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSURE SP

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 8DEG-STER

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code MAX·December 10, 2012

    TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code HSB·June 23, 2015

    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