15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Waterlase Express
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THERMODILUTION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
FDA 510(k)
FDA Class 2
·General Hospital
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·December 23, 2024
UNKNOWN SAPPHIRE PUMP
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·August 6, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Injury
·EITAN MEDICAL LTD.·Product code FRN·March 17, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·May 26, 2026
UNKNOWN SAPPHIRE PUMP
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·February 2, 2026
SAPPHIRE M.T INFUSION PUMP - GERMAN
FDA Adverse Event
Death
·EITAN MEDICAL LTD.·Product code FRN·April 28, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 14, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
LONG GAMMA NAIL, RIGHT 11X340 MM X135
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code JDS·September 15, 2008
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017