BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    Automated Blood Coagulation Analyzer CS-2500

    FDA 510(k)
    FDA Class 2 ·Hematology

    BIS EEG VISTA MONITOR SYSTEM AND BISX

    FDA 510(k)
    FDA Class 2 ·Neurology

    CRAG LATERAL FLOW ASSAY (CRAG LFA)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 22, 2011

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 5, 2013

    35CM BIPOLAR LEAD

    FDA Adverse Event
    Malfunction ·ENPATH MEDICAL·Product code DTB·September 19, 2008

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·May 10, 2023

    BD INTIMA¿-II IV CATHETER

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·June 20, 2023

    LIGASURE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 21, 2022

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012