BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    TECA/MEDELEC AS-10 SENSOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENA HFO COMPOSITE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Flexi-Seal PROTECT Fecal Management System

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

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 9, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 20, 2014

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·December 10, 2012

    RX PERMANENT PACING LEAD

    FDA Adverse Event
    Injury ·OSCOR INC.·Product code DTB·November 19, 2021

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    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