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Ev3 Corporation

USA · Plymouth

✓ 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

40510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 40 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

12 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 3Class III 11Class IV 5

36 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 States0 registration records, 40 510(k), 0 PMA, 11 excluded

Brazil6 confirmed, 3 excluded

Canada19 confirmed, 1 excluded

Manufacturer names merged into this page: EV3 INC. · EV3. INC · EV3, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141118	NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER	2014-07-18
US	K132777	NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER	2013-09-26
US	K130911	RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER	2013-05-24
BR	10349000487	Viance- Cateter de Cruzamento	Class II
BR	10349000448	GUIA BABYWIRE	Class II
BR	10349000440	SISTEMA DE EXCISÃO DE PLACA PERIFÉRICA TURBOHAWK	Class II
CA	83442	POWERCROSS .018" OTW PTA DILATATION CATHETER	Class IV
CA	1472	THE CLOT BUSTER AMPLATZ THROMBECTOMY DEVICE	Class III
CA	3251	INTRACOIL PERIPHERAL VASCULAR STENT	Class IV

Ev3 Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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