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Cordis US Corporation

USA · Miami Lakes

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 8 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

22listed device types

Class I 0Class II 16Class III 6

plus 96 registration records and 4 510(k), 317 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class II 22

42 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

19active device licences

Class II 9Class III 3Class IV 7

63 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

28device registrations

CLASS B 9CLASS D 19

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

29active ARTG entries

Class III 21IIa 6IIb 2

HKHong KongMDACS

10valid listings

Class II 2Class IV 8

ILIsraelAMAR

24registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 1Class 2b 1Class 3 3

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 States96 registration records, 4 510(k), 317 PMA, 15 excluded

Brazil22 confirmed, 5 excluded

Canada19 confirmed, 1 excluded

Manufacturer names merged into this page: Cordis US Corp. · CORDIS US CORP.

FDA 510(k) clearances by year

12022 · K221832

22023 · K232573

12024 · K233637

FDA listed device types

showing 8 of 22

Clamp, Vascular 1Filter, Intravascular, Cardiovascular 1Device, Biopsy, Endomyocardial 1Wire, Guide, Catheter 1Cardiovascular Procedure Kit 1Temporary Carotid Catheter For Embolic Capture 1Cardiac Catheterization Kit 1Set, Administration, Intravascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233637	Cordis BRITECROSS Support Catheter	2024-06-28
US	K232573	INFINITI Ambi Angiographic Catheter	2023-11-21
US	K230704	RAIN Sheath Tibial Pedal Introducer	2023-04-24
BR	81576629001	CATETER DE DILATAÇÃO PARA PTA POWERFLEX PRO	Class II
BR	81576629002	CATETER DE SUPORTE CORDIS ELITECROSS	Class II
BR	81576629003	Cateter de Reentrada OUTBACK Elite	Class II
CA	101851	RAILWAY SHEATHLESS ACCESS SYSTEM	Class II
CA	69225	COURNAND-STYLE NEEDLE	Class II
CA	69507	ANGIOGRAPHIC NEEDLE	Class II

Cordis US Corporation

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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