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

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    SBI HAND FIXATION SYSTEM (TM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306800818·Fomon Lower Lateral Scissors, Strongly Curved, ...

    URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A

    FDA 510(k)
    FDA Unclassified ·Unknown

    AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ORTHOBLAST

    FDA Adverse Event
    Injury ·INTEGRA LIFE SCIENCES·Product code MBP·September 27, 2013

    C21617 DE LIFE SYSTEMS $PHISIO

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

    SIEMENS : ARTISTE MV

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·July 30, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 5, 2011

    ISOFLEX S

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 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