BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM

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

    Benelink module package(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904086194·

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 18, 2020

    POSI-LINK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    C21617 DE LIFE SYSTEMS $PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013

    CAPTIFLEX¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·April 2, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 9, 2011

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 17, 2008

    CP82200 I MIRANDOLA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 6, 2012

    CP85341 FR PARIS

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    EMORY/CL/KNNSTN ATLANTA GA1

    FDA Adverse Event
    Other ·SORIN GROUP USA·Product code DWF·August 19, 2010

    DUKE UNIV DURHAM NC 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·July 15, 2011

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code KFM·November 23, 2016

    COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    SORIN GROUP ITALIA·Product code KFM·February 29, 2016

    REVOLUTION CENTRIFUGAL BLOOD PUMP

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code KFM·July 20, 2018

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code KFM·October 6, 2016

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    SORIN GROUP ITALIA SRL·Product code KFM·October 5, 2016

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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