BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FLO-GARD 8000 INFUSION PUMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONICAL ANGLED ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 9, 2010

    TAXUS¿ ELEMENT¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 10, 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