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

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    DISPOS. PRESSURE KIT 1295K SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS

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

    CeQur Simplicity™ On-Demand Insulin Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·November 22, 2012

    STEM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, INC.·Product code JDH·September 24, 2010

    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