BEUDAMED
    11 results · 18ms · 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.

    FEVER METER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707034146·.014 Upper Stainless Steel Golden International...

    ARCHITECT B12

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SCEPTRE-VS

    FDA 510(k)
    FDA Class 2 ·Radiology

    NATURAYLE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    PULSAR GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    PDS II (POLYDIOXANONE) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code NEW·August 26, 2010

    ARCHITECT B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·September 22, 2025

    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