BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    HEARTWAY Electrically Powered Wheelchairs

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES,

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·August 29, 2023

    DIGIFIX EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCHITECT CA 125 II ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 5, 2025

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code HET·June 3, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 17, 2011

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·August 26, 2008

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES,

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·October 4, 2023

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015