BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    IGG IMMUNOTURBIDIMETRIC & CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704287363·

    RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414452289·RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor, for i...

    COLOCARE

    FDA 510(k)
    FDA Class 2 ·Hematology

    PSK POSTERIOR STABILIZED TOATAL KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·June 25, 2014

    HI-TORQUE PROGRESS 40 GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·February 11, 2013

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    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