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

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    SURGIFLATOR-20 PIM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Neurology

    SMARTTORQUE S609 C

    FDA Adverse Event
    Malfunction ·KAVO DENTAL GMBH·Product code EFB·June 25, 2014

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·February 11, 2013

    AV PLUS DX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

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