BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    SAFEWEDGE(TM) RELIEF VALVE DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080952·Tap 4.5mm (for 5.0mm Screw)

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973875·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973790·

    DURACON PS LIPPED TIBIAL INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUIDEL MOLECULAR INFLUENZA A + B ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    MEDEL S.P.A.·Product code BTI·January 11, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 2, 2010

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code DTB·July 3, 2014

    SYRINGE 10ML 21G 1-1/4IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·February 26, 2020

    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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025