BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    CENTRAL VENOUS PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORA Implant Abutment 5.0mm Cuff (AN)

    FDA UDI
    STERNGOLD DENTAL LLC·00841549112942·The ORA System is indicated for use with dental...

    CONSTI-SSAGE VIBRATOR/MASSAGE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 22, 2025

    CVC SET: 2-LUMEN 7 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·May 22, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·November 22, 2010

    S5 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 4, 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