BEUDAMED
    17 results · 32ms · Sources: EU EUDAMED, US FDA

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    AXI+LINE Proximal Bunion Correction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704920959·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284645·SCALP CONTOUR RETRACTOR 5 1/2" 3X4 SHARP

    Flex Driver

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215057701·

    FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE

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

    UROK ROCKING WHEELCHAIR, MODEL 700-4XX

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BD CONNECTA¿ PLUS WHITE BLEND

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·December 12, 2017

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

    BD CONNECTA¿ STOPCOCKS CONNECTA PLUS WHITE BLEND

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·November 13, 2017

    DEHP FREE LS LF PLUMSET-OL CP D CHAN

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·October 6, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

    TERUMO PERFUSION SYSTEM 9000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code JOR·June 27, 2011

    BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·October 27, 2017

    BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FMG·November 13, 2017

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 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