BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    SUPER DONUT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Coatest APCR Control Plasma Level 1

    FDA UDI
    INSTRUMENTATION LABORATORY COMPANY·08426950088912·Coatest APCR Control Plasma Level 1

    Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate

    FDA 510(k)
    FDA Class 2 ·Dental

    APEX MEDICAL CPAP RT 21XX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 16, 2025

    VANGUARD XP-XP RIGHT MEDIAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·December 22, 2017

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

    ARCHITECT C4000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·November 7, 2012

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 1, 2010

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·Product code FTR·April 28, 2021

    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