27 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Kodiak Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
INVICTUS SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016
SAVI APPLICATOR KIT
FDA 510(k)
FDA Class 2
·Radiology
HOSPIRA INFUSION BLOOD SETS
FDA 510(k)
FDA Class 2
·General Hospital
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 30, 2013
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 18, 2016
Y-SHAPED BLOOD SET W/ PUMP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·September 12, 2013
Y-SHAPED BLOOD SET W/ PUMP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code BRZ·September 13, 2013
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 6, 2013
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 17, 2013
NDEHP Y-BLOOD SET W/FILTER PUMP 203CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 24, 2011
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·August 6, 2013
SOLUSET 100X60W/CAI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 10, 2013
M2A-MAGNUM MOD HD SZ 48MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 21, 2013
MINI-CAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 27, 2011
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·September 30, 2008
SOLUSET 100X60
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 22, 2013
SOLUSET 100X60
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 22, 2013