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St. Jude Medical Cardiovascular Group, Inc.

USA · Rockville

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

63listed device types

Class I 4Class II 36Class III 23

plus 343 registration records and 165 510(k), 561 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 6Class II 11

269 including historic records

SASaudi ArabiaSFDA

35registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

123active device licences

Class II 44Class III 13Class IV 66

231 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States343 registration records, 165 510(k), 561 PMA

Brazil17 confirmed, 0 excluded

Saudi Arabia35 confirmed, 0 excluded

Canada123 confirmed, 0 excluded

Manufacturer names merged into this page: St. Jude Medical · St. Jude Medical, Atrial Fibrillation Division, Inc. · St. Jude Medical, Cardiology Division, Inc. · St. Jude Medical Coordination Center BVBA European Distribution Center · ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION · ST. JUDE MEDICAL SYSTEMS AB

Same-named companies — This database also contains companies with near-identical names: Abbott (St. Jude Medical), ST. JUDE MEDICAL , INC., St. Jude Medical Brasil Ltda., ST. JUDE MEDICAL COSTA RICA LTDA.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12003

22004

42005

102006

72007

132008

142009

142010

122011

112012

112013

112014

42015

132016

32017

42018

32019

42020

12021

12022

FDA listed device types

showing 8 of 63

Electrosurgical, Cutting & Coagulation & Accessories 1Detector And Alarm, Arrhythmia 1Cannula, Catheter 1Stylet, Catheter 1Catheter, Intracardiac Mapping, High-Density Array 1Reprocessed Intravascular Ultrasound Catheter 1Trocar 1Catheter, Intravascular, Diagnostic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223077	ViewFlex Xtra ICE Catheter	2022-12-07
US	K212206	Jot Dx Insertable Cardiac Monitor	2021-08-13
US	K202876	Confirm Rx Insertable Cardiac Monitor	2020-12-01
BR	10332340052	CONJUNTO DE MEDIDORES PARA BIOPROTESE VALVARCARDIACA MODELO B803	Class II
BR	10332340052	CONJUNTO DE MEDIDORES PARA BIOPROTESE VALVARCARDIACA MODELO B803	Class II
BR	10332340275	SISTEMA ENSITE VELOCITY	Class II
SA	ME0000001187SFDAA00002	Transducer Cable	—
SA	ME0000001187SFDAA00003	TactiSys Quartz, TactiFlex Radiofrequency Cable	—
CA	189	AFFINITY PULSE GENERATORS	Class IV
CA	528	PROFILE IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR SYSTEM	Class IV
CA	583	VENTRITEX PR 1500 PROGRAMMER	Class IV

St. Jude Medical Cardiovascular Group, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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