BEUDAMED
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    Vatech Clismile

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 5, 2024

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 9, 2024

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 9, 2024

    CAPSUREEPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVN·November 3, 2014

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JGS·August 23, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·July 8, 2013

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 4, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012