BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    WEBRIL CAST PADDING

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127027772·Bipolar Head Trial, Size 40mm

    VOXAR'S CALCIUM SCORING PRODUCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    FOCUS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ILLICO RETRACTOR (STAINLESS STEEL)

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code LXH·May 20, 2014

    CONTOUR CURVED CUTTER STAPLER

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

    LAMITRODE TRIPOLE 16

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

    ALARIS

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code FRN·June 24, 2020

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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