BEUDAMED
    7 results · 30ms · Sources: EU EUDAMED, US FDA

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    SETUP WALKER ADJUSTABLE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 4, 2012

    CENTURION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 19, 2013

    SUMMIT POR TAPER SZ5 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 22, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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