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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Fetal Doppler U8-25, U9-25

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    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

    PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBAS 6000 C (501) MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 30, 2017

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·November 5, 2014

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SAO PAULO·Product code KPE·September 18, 2011

    ENTERIFLEX FEEDING TUBE

    FDA Adverse Event
    Other ·COVIDIEN·Product code FPD·July 18, 2013