BEUDAMED
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    AUTO TOTAL PROTEIN FOR ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EVOS Small Fragment Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 24, 2014

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 12, 2007

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 3, 2012

    Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·August 29, 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