BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    Alinity h-series System

    FDA 510(k)
    FDA Class 2 ·Hematology

    GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

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

    BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)

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

    REGEN¿ THT® NC: 1.0ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code GIM·June 15, 2022

    NOVASURE

    FDA Adverse Event
    Malfunction ·CYTEC SURGICAL SERVICES, INC.·Product code MNB·November 10, 2008

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE-MOUNTAIN HOME·Product code KDJ·September 12, 2011

    ALTRX +4 10D 40IDX58OD

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 23, 2013

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021