BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES

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

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471149892·K-WIRE - DOUBLE TROCAR FULLY THREADED 2.4mm DIA...

    CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING

    FDA 510(k)
    FDA Not Classified ·Unknown

    MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES

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

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·January 4, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 4, 2011

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·July 21, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024