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

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    Power Wheelchair, W5521

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036733·FPS 8mm Cannulated Phalanx Reamer

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 11, 2024

    SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VYSIS D7S486/CEP 7 FISH PROBE KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 21, 2023

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    ADVANTAGE SERIES 26

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 22, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    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