BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    IPLAN

    FDA 510(k)
    FDA Class 2 ·Neurology

    Safco Micro Applicators

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063750050·Lavender, Regular size Applicator, 2mm 100/tube

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040162351·Channels One Paper Points Large

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717108297·Midway Select Bite Registration Super Fast Set ...

    Disposable Silicone Foley Catheter

    FDA UDI
    Guangdong Baihe Medical Technology Co., Ltd.·06938634484146·

    NEMIO

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·March 26, 2013

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·March 16, 2011

    CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.

    FDA Enforcement
    Class II ·Terminated·ASO, LLC·August 14, 2013

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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