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Medtronic, Ireland

Ireland · Galway Galway

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, South Korea — 4 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

21listed device types

Class I 0Class II 8Class III 12unclassified 1

plus 45 registration records and 9 510(k), 243 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

1active device licences

Class IV 1

TWTaiwanTFDA

16valid device licences

Class II 8Class III 8

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Import 5

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 States45 registration records, 9 510(k), 243 PMA, 56 excluded

Brazil0 confirmed, 25 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada1 confirmed, 19 excluded

Manufacturer names merged into this page: MEDTRONIC IRELAND · MEDTRONIC AVE IRELAND LTD

FDA 510(k) clearances by year

22006 · K061480

12010 · K103095

12013 · K123153

22025 · K252390

32026 · K261428

FDA listed device types

showing 8 of 21

Catheter, Peripheral, Atherectomy 1Endovascular Suturing System 1Catheter, Steerable 1Shunt, Central Nervous System And Components 1Peripheral Mechanical Thrombectomy With Aspiration 1Catheters, Transluminal Coronary Angioplasty, Percutaneous 1Catheter, Percutaneous 1Introducer, Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261428	NC Euphora Rapid Exchange Balloon Dilatation Catheter	2026-08-14
US	K261759	Euphora Rapid Exchange (RX) Balloon Dilatation Catheter	2026-07-27
US	K251970	Sprinter Legend Rapid Exchange Balloon Dilatation Catheter	2026-01-17
CA	10474	BARD PDA UMBRELLA SYSTEM	Class IV

Medtronic, Ireland

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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