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

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    IGG SUCLASS EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    OBC-127 BREAST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 10, 2013

    M2A-MAGNUM MOD HD SZ 52MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 9, 2014

    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