BEUDAMED
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    MiroCam® Capsule Endoscope System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011252617200·ceraMotion® Me 3D Dentin CC4-1, 20 g / dental c...

    NA

    FDA UDI
    Exactech, Inc.·10885862552235·TRIAL, TIBIAL SPACER, SIZE 0, 17 mm

    Metapex Plus

    FDA 510(k)
    FDA Class 2 ·Dental

    FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,

    FDA 510(k)
    FDA Class 2 ·Immunology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014

    IVT DISPOSABLES

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011

    POLYHESIVE RETURN ELECTRODE

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·July 15, 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 E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014