BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    FIXATION MONITOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    24M - Par Electric West Class A FA/Burn

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588226019·24M - Par Electric West Class A FA/Burn

    Legacy

    FDA UDI
    Gc Orthodontics America Inc.·E53582260100001·LEGACY 1. MOLAR UPR LFT SZ 01

    POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FilmArray Pneumonia Panel plus

    FDA 510(k)
    FDA Class 2 ·Pathology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

    IPUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 7, 2012

    SOLETRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO. JUNCOS·Product code MHY·August 27, 2010

    Ingenia Ambition S-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: 781359

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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