23 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROCLUDE-SENSITIVE
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO AUTOJECT MINI
FDA 510(k)
FDA Class 2
·General Hospital
C21617 DE LIFE SYSTEMS $PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 4, 2025
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·April 2, 2013
INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE
FDA Adverse Event
Injury
·VERTEBRAL TECHNOLOGIES, INC.·Product code MAX·March 16, 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
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 29, 2023
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 29, 2023
EMORY/CL/KNNSTN ATLANTA GA1
FDA Adverse Event
Other
·SORIN GROUP USA·Product code DWF·August 19, 2010
UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 30, 2011
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