BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Reform Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set

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

    VERSATAP SUTURE ANCHOR

    FDA Adverse Event
    Malfunction ·ORTHO-DESIGN·Product code MBI·September 15, 2025

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·November 11, 2014

    UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 10, 2011

    S-ROM*INSRT M28,15DEG,28MM

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code KWA·July 23, 2013

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015