83 results · 36ms · Sources: EU EUDAMED, US FDA

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Acurable Limited

FDA registration
Acurable Limited·1 product·🇬🇧 United Kingdom

AcuPebble

FDA UDI
ACURABLE LIMITED·05060759090238·

ISLEEVE 14F

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DYB·September 28, 2020

ISLEEVE 14F

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DYB·April 16, 2025

LOTUS VALVE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NPT·May 13, 2021

EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code NPT·October 19, 2022

ISLEEVE 14F

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DYB·August 21, 2018

VIAFLEX EMPTY IV CONTAINER

FDA Adverse Event
Malfunction ·I.V. SYSTEMS DIV. BAXTER HEALTHCARE CORP.·Product code KPE·July 12, 1996

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 25, 2019

COBALT HV BN CMT 40G-JAPAN

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code LOD·August 13, 2018

LOTUS INTRODUCER SET

FDA Adverse Event
Injury ·CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL·Product code DYB·October 6, 2020

LOGIC PS INSERT SZ 1.5, 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·March 13, 2023

ISLEEVE 14F

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DYB·September 28, 2020

ISLEEVE 14F

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DYB·September 28, 2020

TVT-CAL-EXACT

FDA Adverse Event
Malfunction ·CALDERA MEDICAL·Product code OTN·August 15, 2025

ISLEEVE 14F

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DYB·May 22, 2018

SAPIEN 3 UNKNOWN

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 18, 2020

466FXXXX

FDA Adverse Event
Injury ·CORDIS CASHEL·Product code DTK·June 21, 2018

CURATIVE COLLECTION KIT

FDA Adverse Event
Malfunction ·CURATIVE INC.·Product code QJR·July 20, 2021

466FXXXX

FDA Adverse Event
Injury ·CORDIS CASHEL·Product code DTK·January 19, 2018