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

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    Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD BBL™ Moeller Decarboxylase Broth with Lysine

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902216613·Tube Moeller Decarb Lysine 5Ml 10 Ea

    RINGLOC CONSTRAINED LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EZ-ASSIST-FILL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·August 10, 2016

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·August 10, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·August 24, 2011

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·November 3, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 11, 2013

    BD¿ ONE-WAY VALVE

    FDA Adverse Event
    Injury ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·October 19, 2017

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025