BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    Super Upper Limbs Versalock Plating System

    FDA UDI
    GM DOS REIS INDUSTRIA E COMERCIO LTDA·07901125601321·MINI FRAGMENTS VERSALOCK SUPPORT PLATE 6H

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361014324·Crux Assy, 65-85mm

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361014317·Crux Assy, 45-65mm

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361014300·Crux Assy, 35-45mm

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361014294·Crux Assy, 30-35mm

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 7, 2002

    SPINAL ELEMENTS CERCLAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HELENA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALINITY HQ ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·April 6, 2026

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 20, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 27, 2011

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FGE·September 29, 2008

    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·October 31, 2018