BEUDAMED
    11 results · 38ms · Sources: EU EUDAMED, US FDA

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    Optimus NEURO System - Sterile Kit

    FDA 510(k)
    FDA Class 2 ·Neurology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528103784·7.0 x 110mm Cannulated Screw, 32mm Thd

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528108147·7.0 x 110mm Cann Screw 32Thd Sterile 2Pk

    IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSPIRA HD, MODEL: NL1000

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 14, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 4, 2011

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MAF·September 24, 2008

    HELICAL BLADE INSERTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HSB·May 31, 2024

    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.

    FDA Enforcement
    Class II ·Terminated·Baylis Medical Company Inc.·March 6, 2013

    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