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

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    FridaMom Anti-Nausea Bands

    FDA 510(k)
    FDA Unclassified ·Unknown

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 200, LLC·Product code LRO·September 9, 2025

    MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PEERSCOPE SYSTEM

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

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MAF·November 3, 2008

    C/M INTERCHANGEABLE ULNAR ASSEMBLY

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDC·August 16, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    OEC UroView 2800, fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 31, 2016

    OEC 9800, fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 31, 2016

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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