9 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
FDA Recall
Completed
·Fresenius Kabi USA, LLC·Product code FRN·September 16, 2022
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
FDA Recall
Completed
·Fresenius Kabi USA, LLC·Product code FRN·May 10, 2023
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
FDA Enforcement
Class II
·Completed·Fresenius Kabi USA, LLC·March 20, 2024
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
FDA Enforcement
Class II
·Completed·Fresenius Kabi USA, LLC·March 20, 2024
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024