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

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    WANG BRONCHIAL NEEDLE BRUSH

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DR-2C

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WHEELCHAIR CONVERSION KIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DHS®/DCS® IMPACTOR

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HWA·November 2, 2017

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·CARROLL HEALTHCARE·Product code FNL·February 5, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 3, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 18, 2014

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    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