BEUDAMED
    7 results · 24ms · Sources: EU EUDAMED, US FDA

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    WILTEK STONE EXTRACTOR

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

    NYTONE ENURETIC ALARM BEDWETTING DEVICE

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

    LONG TERM RECORDER RAG 1200

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 25, 2014

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·November 10, 2010

    LAMITRODE TRIPOLE 16

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 20, 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