BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·December 10, 2019

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·April 10, 2014

    UNKNOWN OMNIFIT H A STEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code KWY·October 18, 2012

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·August 17, 2010

    LOGIC CC TIB INSERT SIZE 2, 17MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 10, 2024

    BD SYRINGE S2 5ML 22GA 1-1/4IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·October 29, 2019

    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017