BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    POWERSEAL Sealer and Divider

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

    ALARIS SMARTSITE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026

    VERICOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTOTOME¿ RX 44

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·September 1, 2011

    QUARTET

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·November 6, 2014

    SI BRITE TIP UNKNOWN

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code DYB·July 17, 2013

    UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025

    BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022