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

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    DEKA ACE Pump System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PERIFIX CATHETER CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·April 22, 2026

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 31, 2011

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·July 16, 2013

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·June 2, 2025

    VITEK® 2 AST-YS08 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code NGZ·January 11, 2018

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·September 11, 2025

    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

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