BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    MODIFIED CHICK AMBULATORY HALO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CHOLESTEROL REAGENT FOR DEMAND ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2014

    WALRUS EMBOLECTOMY CATHETER COMPONENT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DXE·June 11, 2010

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·December 21, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

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