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

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    Oh'Care Lite Smart Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOACTYS

    FDA 510(k)
    FDA Class 2 ·Dental

    CRAG LATERAL FLOW ASSAY (CRAG LFA)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 11, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·June 21, 2013

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·September 30, 2008

    POLYETHYLENE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQO·April 5, 2022

    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