BEUDAMED
    20 results · 32ms · Sources: EU EUDAMED, US FDA

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    Acumen Assisted Fluid Management (AFM) Software Feature

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORONIS 5MP

    FDA 510(k)
    FDA Class 2 ·Radiology

    STRAUMANN DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    FDA Adverse Event
    Injury ·KALTENBACH & VOIGT GMBH·Product code EFB·November 19, 2008

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 31, 2011

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code NIO·July 16, 2013

    NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 21, 2026

    SMARTPHONE ANDROID APP: PUMP CONNECT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PKU·August 12, 2025

    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