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

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    SILK SUTURES-REVISED LABELING

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123830·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 200mm

    STAODYN TUWAVE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000

    FDA 510(k)
    FDA Class 1 ·General Hospital

    APTIMA COMBO 2 ASSAY

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code LSL·May 8, 2026

    SPARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTP·January 16, 2013

    SCREW-IN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024