7,020 results · 41ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

(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