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