BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    COLD ROLL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93078209011C0·Titanium Micro Needleholder 9"

    SERRALSILK

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

    HUMAN IGA CSF KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT IRELAND VASCULAR DIVISION REG NO: 9616695·Product code NIM·April 27, 2007

    UNKNOWN LAG SCREW

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code HWC·September 16, 2022

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 13, 2014

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 5, 2012

    FREESTYLE

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC., USA·Product code FMK·September 14, 2007

    UNKNOWN LAG SCREW

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·June 30, 2022

    Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; 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