BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    OXYCARE(TM) OXYGEN CONTROLLER/MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRODIGY ND:YAG SURGICAL LASER SYSTEM

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

    K-DISPERSE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PENTA LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·SJM NEUROMODULATION·Product code LGW·December 7, 2010

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 10, 2014

    ADVANCED BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 14, 2012

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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