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LivaNova USA, INC.

USA · Arvada

✓ 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

22listed device types

Class I 5Class II 15Class III 2

plus 51 registration records and 3 510(k), 241 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

2 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 17Class III 1Class IV 1

47 including historic records

TWTaiwanTFDA

7valid device licences

Class I 1Class II 1Class III 5

SGSingaporeHSA SMDR

3device registrations

CLASS D 3

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

15active ARTG entries

Class I 2Class III 6IIa 5IIb 2

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

4active registrations

Class 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 States51 registration records, 3 510(k), 241 PMA, 2 excluded

Brazil1 confirmed, 2 excluded

Canada19 confirmed, 2 excluded

Manufacturer names merged into this page: LivaNova USA, INC. · LivaNova USA, Inc. · LIVANOVA USA, INC.

FDA 510(k) clearances by year

12024 · K233702

12025 · K250283

12026 · K250937

FDA listed device types

showing 8 of 22

Electrosurgical, Cutting & Coagulation & Accessories 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Dual Lumen Ecmo Cannula 1Tubing, Pump, Cardiopulmonary Bypass 1Apparatus, Autotransfusion 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Dilator, Vessel, For Percutaneous Catheterization 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250937	Venous Return Cannulae	2026-03-11
US	K250283	RAP Femoral Venous Cannulae	2025-07-10
US	K233702	SMARxT Tubing and Connectors	2024-08-08
BR	80483309018	Kit de Dilatação Vascular	Class II
CA	38102	REVOLUTION CENTRIFUGAL BLOOD PUMP	Class III
CA	64967	CORONARY RETRACTION CLIP	Class II
CA	65887	RAPID PRIME SETS	Class II