BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    LINK MP RECONSTRUCTION HIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MONOPOLAR ELECTRODE

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

    CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PROPLEGE CORONARY SINUS DEVICE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DWF·February 11, 2013

    SPL LEAD, TRANSVENOUS

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    PRESIDIO 18 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·July 24, 2014

    SELDRILL-SCHANZSCR Ø5 L200/80 SST

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013

    SELDRILL-SCHANZSCR Ø5 L200/80 SST

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    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