BEUDAMED
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    GILFORD IMMUNOGLOBULIN M REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    CENTERPIECE™ Plate Fixation System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902742774·BONE SCREW 853-469 2.6 X 9MM

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209119752·

    LIPID PROFILE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Cathtong I PICC Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TIMESH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NQW·January 18, 2017

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 6, 2014

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHA·November 30, 2012

    THERMATRX OFFICE THERMO THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC.·Product code MEQ·September 28, 2010

    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