BEUDAMED
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    STS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    CLEARLINK PACLITAXEL SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 24, 2008

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    2.15MM X 25.4MM FLUTED ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    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