BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20408301·Arch wires Titanol Superelastic Straight-Arch-F...

    i-ED COIL

    FDA UDI
    KANEKA CORPORATION·04540778177659·The i-ED COIL is used for vascular embolization...

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023888·BAYONETTED PUSH SCRAPER CURETTE

    CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDER FREE TEXTURED VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COMPLETE

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020

    FUSION TITAN DILATION BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·May 4, 2018

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 8, 2013

    PENUMBRA SYSTEM

    FDA Adverse Event
    Death ·PENUMBRA, INC.·Product code NRY·March 31, 2011

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQC·May 9, 2008

    PF-VIRTEC SYSTEM CMTED LAT.6

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·August 6, 2019

    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