BEUDAMED
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    CURITY CURAD BANDAGES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Oph.Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668119761·Tooke Knife 4 1/2", 2.5x15mm

    Cabo

    FDA UDI
    Seaspine Orthopedics Corporation·10889981079413·9 Level Cervical Plate 26mm

    Cabo™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508101314·1 LEVEL PLATE 26mm

    PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SOZO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code MCN·May 14, 2014

    6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTW·October 31, 2012

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·August 17, 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