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

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    TISSUE CULTURE FLASKS

    FDA 510(k)
    FDA Class 1 ·Hematology

    MODEL ZY PACEMAKER LEAD-VARIOUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    GMK Sphere - Kinematic Alignment

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 5, 2014

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 19, 2010

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-IRELAND·Product code DQY·December 14, 2012

    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