BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    LOMBARD-DOWELL BROTH MEDIUM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Aspiron(TM) Aspiration Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AIMING ARM FOR ANTEGRADE STD LOCKING

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·June 29, 2021

    DUROM US ACETABULAR COMPONENT

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code KWA·June 4, 2014

    SYSTEM 6 ASEPTIC HOUSING ASSY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·October 25, 2010

    OLYMPUS

    FDA Adverse Event
    Malfunction ·OLYMPUS AMERICA, INC.·Product code KOG·November 21, 2012

    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