BEUDAMED
    7 results · 25ms · 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.

    INDENTEC DRILL RA #1

    FDA 510(k)
    FDA Class 1 ·Dental

    SIEMENS SIRECUST 404N NEONATAL MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JAKOBI SURG. INSTRUMENTS #6 50

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A.·Product code GEY·May 20, 2014

    CVC SET: 2-LUMEN 12 FR X 20 CM

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL INC·Product code LFJ·June 11, 2010

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·December 21, 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