BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    ADAPTOR FOR FIBEROPTIC LIGHT SOURCE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    P4 PHYSIO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MENDEC SPINE HV, MENDEC SPINE HV SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 20, 2014

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·April 24, 2012

    MEDICAL PURPOSE COMPUTER; ESOPHAGEAL MANOMETER

    FDA Adverse Event
    Malfunction ·SIERRA SCIENTIFIC INSTRUMENTS LLC·Product code FFX·August 5, 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

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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