BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    SKIN MARKERS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PreView™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788210630·1 Level Preview Plate Caddy

    TREPHINE

    FDA UDI
    Biomet Orthopedics, LLC·00887868048302·

    GREAT TOE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 9, 2014

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 6, 2012

    CCU BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 27, 2010

    Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 28, 2025

    Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 13, 2025

    Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 30, 2025

    Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 6, 2025

    Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 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