BEUDAMED
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    FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197042161·CERA-CUT® Stevens Tenotomy curved...

    GELSPHERES EMBOLIC AGENT

    FDA 510(k)
    FDA Class 2 ·Neurology

    SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 31, 2026

    LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 16, 2023

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code BTI·May 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    ON-X PROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·August 28, 2008

    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