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

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    MOTILITY ORBITAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ULTIMUM/ENGAGE/ENGAGE TR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE CXE1 PUMP UNREFURB

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 4, 2010

    PROMOTE QUADRA

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

    REMB RECIP SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·November 14, 2012

    ULTRACLEAN ELECTRODE 1"BLADE EXTENDED INSULATION

    FDA Adverse Event
    Malfunction ·CONSOLIDATED MEDICAL EQUIPMENT·Product code GEI·January 3, 2020

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014

    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