BEUDAMED
    16 results · 37ms · Sources: EU EUDAMED, US FDA

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    ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM

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

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033393·Baltic Denture System BDLoad BDLoad ↓ Ln6 PLSEu...

    HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAXILLARY DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014

    D903 DIDECO AVANT 2 VAVD PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014

    IT PADOVA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013

    D903 DIDECO AVANT VAVD PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013

    TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSX·February 3, 2017

    ZEPHYR XL SR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·April 3, 2013

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·March 22, 2011

    AMO

    FDA Adverse Event
    Injury ·ADVANCED MEDICAL OPTICS·Product code LPN·April 22, 2008

    C20441 IL HAIFA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DWF·March 28, 2012

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    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