BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

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

    RUGALIFT, MODEL# V.2.1

    FDA 510(k)
    FDA Class 2 ·Neurology

    EON

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 30, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·January 25, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 31, 2014

    PLEURX DRAINAGE KIT 500ML 10/CS

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·July 25, 2025

    PLEURX DRAINAGE KIT 500ML 10/CS

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·December 24, 2024

    PLEURX DRAINAGE KIT 500ML 10/CS

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·December 24, 2024

    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021