BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

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

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code QJR·February 21, 2025

    THERMAGE THERMACOOL SYSTEM

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

    ENDOSCOPE STERILIZATION TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·April 22, 2026

    REF-STAR EXTERNAL REFERENCE PATCH

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·November 14, 2008

    METASUL LARGE DIAMETER HEAD 42/H

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWA·August 30, 2011

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code OTP·July 16, 2013

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·June 2, 2025

    DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES BALSTHAL·Product code KTT·October 16, 2017

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·September 11, 2025