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Maquet Cardiovascular, LLC

USA · Wayne

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

10listed device types

Class I 4Class II 6Class III 0

plus 16 registration records and 16 510(k), 12 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

16active device licences

Class II 4Class III 3Class IV 9

30 including historic records

TWTaiwanTFDA

6valid device licences

Class I 6

SGSingaporeHSA SMDR

11device registrations

CLASS B 4CLASS C 5CLASS D 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

15active ARTG entries

Class I 4Class III 1IIa 8IIb 2

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

14active registrations

Class 2a 5Class 2b 3Class 3 6

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 States16 registration records, 16 510(k), 12 PMA, 16 excluded

Brazil1 confirmed, 10 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada16 confirmed, 4 excluded

Manufacturer names merged into this page: Maquet Cardiovascular LLC · MAQUET CARDIOVASCULAR LLC

FDA 510(k) clearances by year

12008

12009

12010

22011

12012

22013

22016

12019

12020

12024

22025

12026

FDA listed device types

showing 8 of 10

Stabilizer, Heart 1Catheter, Irrigation 1Instruments, Surgical, Cardiovascular 1Cutter, Surgical 1Electrosurgical, Cutting & Coagulation & Accessories 1Prosthesis, Vascular Graft, Of Less Then 6mm Diameter 1Laparoscope, General & Plastic Surgery 1Lavage, Jet 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252445	Fusion Bioline Vascular Graft	2026-04-27
US	K251238	Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)	2025-05-30
US	K243918	Vasoview Hemopro 3 Power Supply	2025-02-26
BR	80259110169	Mecanismo de Acionamento Ultima Activator II	Class I
CA	1387	HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT	Class IV
CA	1398	MICROVEL DOUBLE VELOUR GRAFT WITH GUIDELINE	Class III
CA	1454	HEMASHIELD WOVEN DOUBLE VELOUR CARDIOVASCULAR FABRIC	Class IV