BEUDAMED
    8 results · 37ms · Sources: EU EUDAMED, US FDA

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    VORTECH 3M NETWORK PRINTING

    FDA 510(k)
    FDA Class 2 ·Radiology

    QBC AUTOREADER

    FDA 510(k)
    FDA Class 2 ·Hematology

    INTAVENT LARYNGEAL MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 15, 2013

    UNIDENTIFIED ENDULANCE HEAD 28 MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.1818910·Product code KWA·July 4, 2014

    TWISTER PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGX·June 25, 2015

    UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·July 5, 2024

    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