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

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    MICROLYTE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AGILITY ANKLE REVISION PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CVC SET: 2-LUMEN 5 FR X 13 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DQY·April 11, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 4, 2012

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·August 31, 2010

    BD PLATE CAMPYLOBACTER SB 100MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 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