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

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    THE LUOMANEN ORAL AIRWAY

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Oph.Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668119754·Gill Corneal Knife, Curved 3.5mm Blade

    Urethrotomy knife

    FDA UDI
    SOPRO-COMEG GmbH·04059082029849·

    Breast BI 7 MR Coil 1.5T Mammavention

    FDA 510(k)
    FDA Class 2 ·Radiology

    PCL TIGHTROPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 4, 2014

    PK DISSECTING FORCEPS

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·October 31, 2012

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 16, 2010

    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