16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
FDA 510(k)
FDA Class 2
·Orthopedic
OPTECURE +CCC
FDA 510(k)
FDA Class 2
·Orthopedic
CAVIOS CAVITY LINER
FDA 510(k)
FDA Class 2
·Dental
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
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
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·July 7, 2011
TROCHANTERIC NAIL KIT, TI 11X180MM X 130
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code JDS·September 15, 2008
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017