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

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    SURGICAL LOUPES

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

    Straumann Mini Implants

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCESSORIES FOR SYS. 400 CO2 SURG. LASER

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

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 5, 2010

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 10, 2014

    3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 5 HOLES-RIGHT

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code KTT·December 31, 2012

    SPRINT QUATTRO SECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·May 20, 2021

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 15, 2019

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 15, 2019

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·May 15, 2019

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·May 15, 2019

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    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