BEUDAMED
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    TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

    AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Electromed SmartVest Airway Clearance System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GAG·January 14, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 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