BEUDAMED
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    FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXE·November 27, 2024

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXE·February 4, 2026

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·March 13, 2025

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DXE·September 5, 2025

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·February 11, 2025

    Bard® Urine Meter Foley Catheter Tray, Bardex® All-Silicone Temp-Sensing Foley

    FDA UDI
    C. R. Bard, Inc.·00801741029325·Bard® Urine Meter Foley Catheter Tray With Bard...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198659·AK3 Ultra Insert Trial Size 4, 10mm

    ZS3 and z.one pro Ultrasound Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELVI SGOT & SGPT TRANSAMINASE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 24, 2014

    ITREL 3

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·November 3, 2010

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·December 18, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; 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