BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902575679·INSTRUMENT 8981330 THOR TIP 30MM BOTTOM

    n/a

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000878696·INSTRUMENT 8981330 THOR TIP 30MM BOTTOM

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981330·anteriors; shade C4; mould BM2

    CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NeoMatriX Wound Matrix

    FDA 510(k)
    FDA Unclassified ·Unknown

    UMBILICAL CATHETER

    FDA Adverse Event
    Malfunction ·VYGON·Product code FOS·February 17, 2021

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 2, 2011

    INSORB SKIN STAPLER

    FDA Adverse Event
    INCISIVE SURGICAL·Product code GDT·July 24, 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