7,020 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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(HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS - HOUSTON·Product code LYJ·April 3, 2020
CENTRALINK DATA MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JQP·February 9, 2015
LEAD MODEL 304
FDA Adverse Event
Malfunction
·CYBERONICS - HOUSTON·Product code LYJ·June 25, 2020
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·April 17, 2024
PIPELINE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·February 24, 2022
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·February 24, 2022
PIPELINE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·February 2, 2022
LEAD MODEL 302
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·July 10, 2020
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·August 21, 2015
REFLEX CATHETER
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·April 15, 2024
SOLITAIRE RD
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·April 15, 2024
PIPELINE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·August 27, 2025
PHENOM CATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code QJP·August 27, 2025
MARKSMAN
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·August 27, 2025
PIPELINE FLEX EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 3, 2021
PIPELINE FLEX EMBOLIZATION DEVICE
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 3, 2021
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code HCG·December 29, 2022
THERMOCOOL SMARTTOUCH SF
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·January 15, 2026
LEAD MODEL 302
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code MUZ·January 8, 2021