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Home›USA›MEDTRONIC COREVALVE LLC

MEDTRONIC COREVALVE LLC

USA · Santa Ana
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 8 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
7510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 7 510(k), 1 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
2active device licences
Class II 1Class IV 1
8 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
4device registrations
CLASS D 4
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1Class III 1
HKHong KongMDACS
3valid listings
Class IV 3
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
6active registrations
Class 2b 1Class 3 5
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, 7 510(k), 1 PMA, 3 excluded
Brazil1 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: MEDTRONIC COREVALVE LLC · MEDTRONIC HEART VALVES DIVISION/MEDTRONIC COREVALVE LLC
Same-named companies — This database also contains companies with near-identical names: MEDTRONIC HEART VALVES DIVISION/MEDTRONIC COREVALVE LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Santa Ana

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11991
11992
11995
11996
11998
12015
12018

Registration details (sample)

MarketIdentifierNameClass / date
USK181001Medtronic Confida Brecker Guidewire2018-05-03
USK150465Medtronic Confida Brecker Guidewire2015-08-03
USK980534DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H1998-04-30
BR10349000688Sistema de Carregamento EnVeo PROClass I
CA89391COREVALVE TRANSCATHETER AORTIC VALVE (TAV)Class IV
CA89418COREVALVE DELIVERY CATHETER SYSTEMSClass II

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