BEUDAMED
    19 results · 37ms · Sources: EU EUDAMED, US FDA

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    ULTRACHEM E-GLU, #64976 & 65040

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268214611·CUSTOM SURGICAL KIT VASCULAR VEIN PACK

    STERLING

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975064295·

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M7526821461R21·CUSTOM SURGICAL KIT VEIN PACK

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M7526821461R11·CUSTOM SURGICAL KIT, VEIN PACK

    ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BACT/ALERT FA PLUS CULTURE BOTTLE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 2, 2018

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·June 13, 2018

    PULSAR GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 15, 2014

    TRIAGE PROFILER SOB PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·August 27, 2010

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 31, 2018

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 28, 2018

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 2, 2014

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·August 22, 2017

    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