BEUDAMED
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    Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813034224·Hedstrom Files with Silicone Stops 31mm #45

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464093854·HEARLINK 1500 MNR TP

    RESSCAN

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LOOP LED Curing Light System

    FDA 510(k)
    FDA Class 2 ·Dental

    GOODTECH

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL INC.·Product code DYG·December 1, 2008

    *

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·August 28, 2011

    HARMONIC ACE+

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·July 25, 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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013