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

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    VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Enteral Feeding Syringes with Enfit Connectors

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

    SYNTHES 90 DEGREE SCREWDRIVER

    FDA 510(k)
    FDA Class 2 ·Dental

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 16, 2014

    SUPER POLIGRIP EXTRA CARE

    FDA Adverse Event
    Injury ·Product code KOT·February 21, 2013

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·February 9, 2011

    3.2MM WIRE GUIDE SLEEVE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·April 28, 2023

    1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code DZI·May 19, 2015

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40

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