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Home›USA›Guidant Cardiac and Vascular Surgery

Guidant Cardiac and Vascular Surgery

USA · Menlo Park
✓ 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
15510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 1Class II 2
22 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
6active device licences
Class II 6
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, 15 510(k), 0 PMA, 3 excluded
Brazil3 confirmed, 0 excluded
Canada6 confirmed, 4 excluded
Manufacturer names merged into this page: GUIDANT CORPORATION CARDIAC SURGERY · CARDIAC PACEMAKERS INCORPORATED (UMA SUBSIDIÁRIA DA GUIDANT CORPORATION, UMA SUBSIDIÁRIA D · CARDIAC PACEMAKERS INCORPORATED (UMA SUBDISIÁRIA DA GUIDANT CORPORATION/UMA SUBSIDIÁRIA DA · CARDIAC PACEMAKERS INCORPORATED (UMA SUBSIDIÁRIA DA GUIDANT CORP. E BOSTON SCIENTIFIC CORP
Same-named companies — This database also contains companies with near-identical names: Guidant Corporation, Cardiac Surgery. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Menlo Park

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

31997
12000
22001
52002
22003
12004
12008

Registration details (sample)

MarketIdentifierNameClass / date
USK080169HEARTSTRING III PROXIMAL SEAL SYSTEM2008-02-08
USK041340GUIDANT MICROWAVE ABLATION SYSTEM2004-07-28
USK023630ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-14002003-02-20
BR10341350596FERRAMENTA DE FIXAÇÃO PARA ELETRODOSClass I
BR10341359001VEIN PICKClass II
BR10341350556CHAVE DE TORQUE BIDIRECIONALClass II
CA5154CARDIAC STABILIZERClass II
CA5159CARDIAC MANIPULATORClass II
CA11947CTS MIDCAB SYSTEMClass II

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