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Cook

FDA UDI
COOK INCORPORATED·00827002178977·Chiba Needle

SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL·Product code DRF·May 26, 2022

ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL·Product code DRF·May 26, 2022

6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027

FDA 510(k)
FDA Class 2 ·Cardiovascular

SUPREME

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL CARDIOVASCULAR DIVISION·Product code DRF·August 29, 2022

SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code DRF·May 26, 2022

SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL·Product code DRF·March 31, 2021

SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code DRF·July 29, 2025

SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL·Product code DRF·January 13, 2021

SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code OBJ·November 17, 2017

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·June 4, 2024

SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code DRF·September 17, 2025

RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, EL

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code DRF·June 16, 2025

SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, COSTA RICA LTDA·Product code DRF·February 24, 2020

TRANSSEPTAL NEEDLE, BRK SERIES

FDA Adverse Event
Injury ·ST. JUDE MEDICAL AF DIVISION·Product code DRC·September 19, 2011

SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·June 12, 2023

SUPREME EP CATHETER 6F, QUADRIPOLAR, JSN

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, AF DIV.·Product code DRF·December 14, 2011

THERAPY COOL FLEX, 1304-CF-7-0.5(5)2

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, IRVINE·Product code OAD·August 23, 2012

NA

FDA Adverse Event
Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS PHOENIX·Product code NLH·June 14, 2019

NA

FDA Adverse Event
Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS PHOENIX·Product code NLH·June 27, 2016