BEUDAMED
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    INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981340·anteriors; shade C4; mould IL2

    PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cemented TSI Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MARATHON MICRO CATHETER

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code DYG·February 27, 2013

    INSERT, BIPOLAR FORCEPS

    FDA Adverse Event
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.·Product code GEI·July 25, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 2, 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