BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    RAPI/TEX-LGM KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Insulin Algorithms System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PEDIATRIC URETERAL STENT

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

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·April 7, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 26, 2012

    LUMENIS ONE

    FDA Adverse Event
    Injury ·LUMENIS LTD. YOKNEAM·Product code GEX·July 14, 2010

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025