Home›USA›Edwards Lifesciences, LLC

Edwards Lifesciences, LLC

USA · Midvale

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

59listed device types

Class I 13Class II 39Class III 6unclassified 1

plus 203 registration records and 175 510(k), 1,178 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

41registered devices

Class I 13Class II 28

158 including historic records

SASaudi ArabiaSFDA

11registered imported devices

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

CACanadaMDALL

88active device licences

Class II 63Class III 6Class IV 19

199 including historic records

TWTaiwanTFDA

27valid device licences

Class I 3Class II 16Class III 7未分级 1

SGSingaporeHSA SMDR

25device registrations

CLASS B 4CLASS C 5CLASS D 16

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

83active ARTG entries

Class I 14Class III 45IIa 15IIb 5Class Is (sterile) 4

HKHong KongMDACS

16valid listings

Class II 2Class III 3Class IV 11

ILIsraelAMAR

40registrations

RURussiaRoszdravnadzor

10active registrations

Class 2a 1Class 2b 1Class 3 8

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.

Australia, Hong Kong, Saudi Arabia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States203 registration records, 175 510(k), 1,178 PMA, 6 excluded

Brazil41 confirmed, 0 excluded

Saudi Arabia11 confirmed, 0 excluded

Canada88 confirmed, 0 excluded

Manufacturer names merged into this page: EDWARDS LIFESCIENCES TECHNOLOGY SARL · CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG · EDWARDS LIFESCIENCES LLC · Edwards Lifesciences LLC · EDWARDS LIFESCIENCES · EDWARDS LIFESCIENCES (CANADA) INC.

Same-named companies — This database also contains companies with near-identical names: Edwards Lifesciences Holding B.V., EDWARDS LIFESCIENCES (CANADA) INC., EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA, Edwards Lifesciences Ireland Limited. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22007

32008

62009

72010

72011

72012

72013

102014

62015

62016

42017

72018

82019

72020

52021

82022

102023

112024

92025

52026

FDA listed device types

showing 8 of 59

Oximeter 1Probe, Thermodilution 1Catheter, Intravascular, Diagnostic 1Medium-Term Adjunctive Predictive Cardiovascular Indicator 1Transducer, Pressure, Catheter Tip 1Clamp, Vascular 1Adjunctive Predictive Cardiovascular Indicator 1Catheter, Continuous Flush 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254232	ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)	2026-06-26
US	K251326	Respiration Rate algorithm	2026-06-11
US	K260105	Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts	2026-06-05
BR	80219050194	Sondas de Temperatura do Injetado - CO-Set	Class I
BR	80219059007	Manípulo Universal	Class II
BR	80219059008	Manípulo para Anel de Anuloplastia	Class II
CA	24580	EDWARDS MIRA BILEAFLET PROSTHESIS	Class IV
CA	20410	STILLSITE STABILIZER	Class II
CA	38673	PRECISION-OP SYSTEM	Class II