BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN

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

    n/a

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074547510·PADDLE SHAVER 2941312 12MM LATERAL

    STERILUCENT PROCESS CHALLENGE DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NOBELRONDO DENTAL CERAMIC-ALUMINA

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDO GIA STAPLER

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GDW·January 25, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 16, 2010

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECORE CORPORATION·Product code MVK·April 11, 2014

    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