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

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    VYGON ENTERNAL NUTRITION TUBES

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

    HDR MIAMI APPLICATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    SENZZZZZ AWAY

    FDA 510(k)
    FDA Class 2 ·Dental

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 30, 2007

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012

    TLC Self -Retaining Retractor System-5/box Product Number:820-176

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GAD·October 25, 2005

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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