373 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Premier Resolution System
FDA 510(k)
FDA Class 2
·Hematology
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
KUSKE BREAST APPLICATOR SET, MODEL 189.006
FDA 510(k)
FDA Class 2
·Radiology
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014
IDC¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·August 25, 2011
M2A-MAGNUM PF CUP 50ODX44ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 12, 2013
3T HEATER/COOLER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·March 19, 2026
HEATER-COOLER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·October 1, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
HEATER-COOLER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·April 30, 2026
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·October 10, 2025
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 3, 2025
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·October 10, 2025
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·April 22, 2026
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUSTCHLAND·Product code DWC·April 7, 2026
HEATER-COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·March 26, 2026
HEATER-COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·February 10, 2026
HEATER-COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 20, 2026
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 23, 2026
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·April 16, 2026