BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    GAMMA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD 3700 SL

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007

    UBI MAGIWEL CORTISOL QUANTITATIVE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    V-CATH BREAKAWAY NEEDLE INTRODUCER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PCA PLS II

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD·Product code MEA·June 12, 2014

    ENTRUST VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 11, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·January 10, 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