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

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    ROUND SILICONE DRAIN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515203501·Curette Excavator, SE, 4mm cup, 5", without hole

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111297847·JACKSON TRACH TUBE #8-4 PIECES

    LASERPEEL SOFT-MET MODIFIED ERBIUM LASER

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

    GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 30, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·May 19, 2015

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·May 13, 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