BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    FLUOROSTAT FLUOROMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788227010·Cervical Rasp, Thin Shaft, 8x16x13, 6 deg

    MANTA Laser

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

    POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·July 14, 2020

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·February 12, 2014

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·November 7, 2012

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 27, 2010

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·February 23, 2018

    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

    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