BEUDAMED
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    RAD-291

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Stowe Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TOKUYAMA TISSUECARE

    FDA 510(k)
    FDA Class 2 ·Dental

    TARGET 360 SOFT 5MM X 20CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR CORK·Product code HCG·April 30, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 22, 2007

    TALENT TAA STENT GRAFT

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 10, 2012

    NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024