BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    LASER BRONCHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    STYLE 10 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·July 23, 2021

    VITREAVIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cryo-Thermo Compression Device (FGK002)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 20, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·October 9, 2012

    AVALON ELITE

    FDA Adverse Event
    Death ·AVALON LABORATORIES LLC·Product code DWF·August 26, 2010

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    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