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

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    HELENA THROMBOPLASTIN-MI REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Peristeen Anal Irrigation System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 19, 2014

    DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 24, 2015

    SILICONE ADVANCED OPTIC LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·December 17, 2010

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020