BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517332738·Fixed Screw Driver

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690129783·Modular Tibia Fluted Keel Stem, Size 10mm x 100mm

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506082559·REUSABLE LIGHTWEIGHT IRRIGATION/SUCTION SYSTEM ...

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Guardant360® Liquid CDx

    SPACELABS HEALTHCARE

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522122668·10 ELECTRODE PT.CABLE, SHORT.BA

    LAPAROCISION SCOPE CONTROLLER SYSTEM

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

    CYMA

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

    CERTAIN GOLD-TITE TM HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·April 3, 2025

    Apex Lifts

    FDA UDI
    JOERNS HEALTHCARE, LLC·00810055881130·C-HLA-2 W/MESH SM U-SLING W/ HD SUPPORT

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 13, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 15, 2011

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·July 24, 2013

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·July 3, 2024

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013