BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    X-RAY DETECTABLE LAP SPONGES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HbA1c Advanced

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CERTAS THERAPY MGMT SYSTEM

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF·Product code JXG·May 15, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012

    DRILL-FREE CROSS-DRIVE MINI SCREW

    FDA Adverse Event
    Injury ·KARL LEIBINGER GMBH U. CO. KG·Product code DZL·August 17, 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