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

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    Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114094·SIMCOE CORTEX EXTRACTOR 23GA 0.4MM PK/10

    Speedicath Compact Male

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SubtleMR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·November 7, 2008

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 31, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2013

    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