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

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    Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BONEMEDIK, AND BONEMEDIK-S

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEGION POROUS + HA TIBIAL BASEPLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·June 5, 2013

    PRIMARY IV PLUM SET

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code FPA·July 12, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DYB·August 31, 2021

    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

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DYB·June 8, 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

    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

    Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021