BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    POLYCARB WATER SET

    FDA 510(k)
    FDA Class 2 ·Dental

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209119547·KIT, INDIVIDUAL FIRST AID - CUSTOM

    MAGNETOM Spectra

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHROCARE PERC-D SPINEWAND

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

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·June 6, 2014

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 30, 2012

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 28, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

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