BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    OTE BIOMEDICA NEUROGRAPH 14

    FDA 510(k)
    FDA Class 2 ·Neurology

    VARILIFT -C

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

    FDA 510(k)
    FDA Class 2 ·Immunology

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A.·Product code GFA·April 1, 2014

    FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·October 30, 2012

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·September 12, 2007

    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