BEUDAMED
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    FINGER TOURNIQUETTE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209119882·KIT, CUSTOM KOC-V2

    Quiver Laparoscopic Extendable

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HOFFMANN II MRI EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 4, 2014

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    FDA Adverse Event
    Malfunction ·ACCESSCLOSURE, INC.·Product code MGB·November 30, 2012

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 5, 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