BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    Axium Detachable Coil; Axium Prime Detachable Coil

    FDA 510(k)
    FDA Class 2 ·Neurology

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551082270·Micro Elevator, curved, 1 mm, 17,5 cm

    EcoFit® Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRANQUILL BARBED DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·February 3, 2019

    GLUCOMETER ELITE 4 DATE

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·January 20, 2006

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 2, 2011

    S-ROM*STM STD,36NK,18X13X160

    FDA Adverse Event
    Injury ·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code JDI·July 18, 2013

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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