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TERUMO CARDIOVASCULAR SYSTEM CORPORATION

USA

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

33listed device types

Class I 5Class II 27Class III 1

plus 77 registration records and 75 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

36active device licences

Class II 26Class III 10

69 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 States77 registration records, 75 510(k), 0 PMA, 42 excluded

Brazil6 confirmed, 14 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada36 confirmed, 9 excluded

Manufacturer names merged into this page: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION · Terumo Cardiovascular Costa Rica LLC · TERUMO CARDIOVASCULAR SYSTEMS THI PLANT · TERUMO CARDIOVASCULAR SYSTEMS CORP. · TERUMO CARDIOVASCULAR COSTA RICA, LLC · TERUMO CARDIOVASCULAR SYSTEM CORPORATION

FDA 510(k) clearances by year

42003

32004

22005

22006

32007

32008

72009

22010

22011

32012

32013

72014

102015

22016

22017

32018

12021

12023

12024

12025

FDA listed device types

showing 8 of 33

Electrosurgical, Cutting & Coagulation & Accessories 1Heat-Exchanger, Cardiopulmonary Bypass 1Controller, Temperature, Cardiopulmonary Bypass 1Cpb Check Valve, Retrograde Flow, In-Line 1Detector, Bubble, Cardiopulmonary Bypass 1Laparoscope, General & Plastic Surgery 1Reservoir, Blood, Cardiopulmonary Bypass 1Filter, Bacterial, Breathing-Circuit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250684	OPUSWAVE Dual Sensor Imaging System	2025-07-02
US	K234065	CDI OneView Monitoring System	2024-04-25
US	K221895	Terumo Advanced Perfusion System 1	2023-04-18
BR	80012280016	OXIGENADOR DE FIBRAS OCAS CAPIOX SX COM RESERVATORIO RIGIDO TERUMO	Class II
BR	80012280097	CUVETA H/S CDI TERUMO	Class II
BR	80012280095	SENSOR SHUNT TERUMO	Class II
CA	24421	ARTERIAL FILTERS WITH X-COATING	Class II
CA	25855	SARNS CENTRIFUGAL PUMP	Class III
CA	63930	CAPIOX FLEXIBLE VENOUS RESEVOIR	Class II

TERUMO CARDIOVASCULAR SYSTEM 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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