BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    ROTOSNARE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CHEM-STRATE CK-NAC

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701

    FDA 510(k)
    FDA Class 2 ·Neurology

    MINI QA+ #0 ETH OS-2 *EA

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HWC·May 9, 2018

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 7, 2013

    ATTAIN STARFIX

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·February 15, 2011

    SELECTSECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·August 8, 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