93 results
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79ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORE12
FDA UDI
APPLIED CARDIAC SYSTEMS, INC.·00853512007001·Multi Function Device
HOLTER MONITOR
FDA Adverse Event
Malfunction
·APPLIED CARDIAC SYSTEMS, INC.·Product code DRT·July 1, 1993
SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
FDA Adverse Event
Death
·SHOCKWAVE MEDICAL, INX.·Product code QMG·April 13, 2023
SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
FDA Adverse Event
Death
·SHOCKWAVE MEDICAL, INC.·Product code QMG·April 18, 2023
SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
FDA Adverse Event
Injury
·SHOCKWAVE MEDICAL, INC.·Product code QMG·April 14, 2023
SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
FDA Adverse Event
Death
·SHOCKWAVE MEDICAL, INC.·Product code QMG·April 18, 2023
SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
FDA Adverse Event
Injury
·SHOCKWAVE MEDICAL, INC.·Product code QMG·April 18, 2023
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·May 19, 2025
THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·August 9, 2018
DAVINCI XI
FDA Adverse Event
Death
·INTUITIVE SURGICAL, INC·Product code NAY·November 21, 2023
THERMOCOOL SMARTTOUCH SF
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·May 21, 2026
OCTARAY MAPPING CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code MTD·February 3, 2025
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·August 22, 2023
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DRC·April 1, 2025
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code MMI·September 26, 2011
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·March 10, 2025
LASSO® NAV ECO VARIABLE CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DRF·March 5, 2024
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER A
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 12, 2024
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·May 7, 2019
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC.·Product code LPB·May 15, 2019