BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    HEM-O-LOK XL CLIP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ImmuLINK

    FDA UDI
    IMMUCOR, INC.·10888234002475·ImmuLINK is middleware software that allows the...

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024069·Paddle Shaver, 11mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103110·Shaver, Closed, 11mm

    NUTRISAFE PUR ENTERAL FEEDING TUBE

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

    PARAPOST FIBER WHITE

    FDA 510(k)
    FDA Class 1 ·Dental

    Widex

    FDA UDI
    Widex A/S·05706069718478·Widex EVOKE E-F2 110 DEMO (Silver Grey ) Teleco...

    CRYSTALENS HD IOL

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·March 28, 2013

    KENTROX SL-S 65/16 STEROID

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·March 21, 2011

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·April 15, 2008

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. 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. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide 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, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016