BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    IGA IMMUNOTURBIDIMETRIC & CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    AD-HEAR

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    PALL 3N1 FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    G7 HI-WALL E1 LINER 36MM G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·November 30, 2021

    36MM COCR MOD HD +9MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·November 30, 2021

    TI COLLAR WITH GROOVES

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

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

    FOXCROSS PTA CATHETER

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

    TENDRIL SDX

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

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

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