1,089 results · 31ms · Sources: EU EUDAMED, US FDA

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MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD

FDA 510(k)
FDA Class 3 ·Cardiovascular

THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 19, 2024

WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 14, 2024

BLEPHEX TREATMENT

FDA Adverse Event
Malfunction ·BLEPHEX, LLC·Product code PYU·May 27, 2021

BLEPHEX

FDA Adverse Event
Malfunction ·BLEPHEX LLC·Product code PYU·February 3, 2026

BLEPHEX

FDA Adverse Event
Malfunction ·BLEPHEX, LLC·Product code PYU·February 3, 2026

BLEPHEX

FDA Adverse Event
Malfunction ·BLEPHEX, LLC·Product code PYU·February 3, 2026

TECNIS IOL

FDA Adverse Event
Injury ·AMO MANUFACTURING NETHERLANDS·Product code MFK·July 20, 2021

UNKNOWN PICO

FDA Adverse Event
Injury ·SMITH & NEPHEW MEDICAL LTD.·Product code OMP·October 5, 2023

UNKNOWN PICO

FDA Adverse Event
Injury ·SMITH & NEPHEW MEDICAL LTD.·Product code OMP·October 5, 2023

UNKNOWN PICO

FDA Adverse Event
Injury ·SMITH & NEPHEW MEDICAL LTD.·Product code OMP·October 5, 2023

WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 14, 2024

REFLEX CATHETER

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·March 20, 2025

UNKNOWN PICO

FDA Adverse Event
Injury ·SMITH & NEPHEW MEDICAL LTD.·Product code OMP·October 5, 2023

WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 14, 2024

UNK_NAVISTAR THERMOCOOL

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code OAD·August 31, 2021

UNK_LASSO

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code DRF·August 31, 2021

UNK - CONSTRUCTS: 3.5 MM LCP T-PLATE

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HRS·May 11, 2026

THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

FDA Adverse Event
Death ·BIOSENSE WEBSTER INC·Product code LPB·March 19, 2024

UNK - CONSTRUCTS: LCP

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HRS·May 11, 2026