BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    AlloMap Heart Molecular Expression Testing

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074362304·SCREW 7221640 HA COATED CANN 6.5 X 40

    Steril Peel

    FDA UDI
    AMD Medicom Inc·D830221640·STERIL-PEEL Heat Seal Sterilization Pouch Size ...

    Vu aPod™ - L

    FDA UDI
    Seaspine Orthopedics Corporation·10889981046576·LATERAL TRIAL, WIDE, STANDARD, 16mm X 23mm X 40mm

    ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HANSATOME EXCELLUS MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·August 24, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 3, 2014

    THERMOPHORE AUTOMATIC

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·July 1, 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