BEUDAMED
    13 results · 18ms · Sources: EU EUDAMED, US FDA

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    IVEX-HP PEDIATRIC EXTENSION SET-SL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PreView™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788210130·Drill 16 mm-Cervical

    10PW - Wisconsin Energy Corp

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588210131·10PW - Wisconsin Energy Corp

    Unipack

    FDA UDI
    UNIPACK MEDICAL CORPORATION·D784UBC8210131·Oral Camera Covers Digital Doc, Iris

    CONNEX VITAL SIGNS MONITOR 6000 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    ALIGN R URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·October 26, 2012

    LANGSTON

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS, INC.·Product code DQO·August 31, 2010

    Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 2, 2024

    Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·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