BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    QUANTIEN Measurement System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: QWH-420 WRIST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURGICAL GUT SUTURE - CHROMIC

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAL·May 15, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·August 18, 2010

    UNKNOWN KNEE COMPONENT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 7, 2025

    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