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

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    TECHNICON CHEM 1(TM) SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PILLING HEMOSTATIC CLIP APPLIER FORCEPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·May 30, 2024

    BARD FLAT MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 10, 2014

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012

    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