BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    TENDERWET ACTIVE

    FDA 510(k)
    FDA Unclassified ·Unknown

    Jelly Tab Sensors

    FDA UDI
    Natus Medical Denmark ApS·05713315011740·ALGO Jelly Tab Sensors

    BABY CONTROL COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·November 12, 2012

    ALGO Hearing Screening Supplies

    FDA UDI
    NATUS MEDICAL INCORPORATED·00382830046183·Jelly Tab Sensors

    LIFE SCOPE EC, MODEL BSM-1102

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANTA SST GRAFT (<6MM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·March 11, 2013

    UNSPECIFIED SYSTEM

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·March 18, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·May 9, 2008

    Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·November 24, 2021

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    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