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

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    CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)

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

    Approach CTO Microwire Guide

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DINAMAP MODEL 837

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 16, 2013

    FOUNDATION SHOULDER

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·January 19, 2011

    SEE H-10

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·July 31, 2014

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·Product code DQX·May 21, 2021

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·December 28, 2021

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 17, 2023

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 3, 2023

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·October 31, 2023

    LILLIPUT 2

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·November 3, 2023

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012