BEUDAMED
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    Intelligence LaserComb

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    WADiana Compact

    FDA UDI
    DIAGNOSTIC GRIFOLS SA·08437014205183·WADiana Compact is a fully automated analyzer d...

    MODULAR PROXIMALLY FLUTED HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNK GEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·November 8, 2019

    AMPLATZER TALISMAN PFO OCCLUDER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code MLV·November 22, 2022

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·October 28, 2008

    ON Q PAINBUSTER

    FDA Adverse Event
    Malfunction ·I-FLOW CORP·Product code MEB·April 9, 2008

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    CONNECTA WHT 360DEG TB 30CM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·April 16, 2026

    CONNECTA WHT 360DEG TB 30CM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·April 20, 2026

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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