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

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    TECNOL NASO-GASTRIC TUBE HOLDER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Dornier MINNOW Ureteral Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GRACE DYNAMIC TORP

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

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

    NDEHP LS TWN 2CLVE

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·December 21, 2012

    SP2 TIBIAL RADEL IMPACTOR

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·June 24, 2014

    G7 HI-WALL E1 LINER 36MM F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·December 4, 2018

    TPRLC 133 FP TYPE1 BM SO 11.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 4, 2018

    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