BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    SERO/TEX RF TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    BD Alaris™ Pump Epidural Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZIO PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 28, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 6, 2012

    I-STAT G3+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JJE·August 26, 2010

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    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