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Pacesetter Systems

USA · Mchenry
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
96510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 96 510(k), 19 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
0active device licences
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, 96 510(k), 19 PMA, 2 excluded

Company information

Country
USA
City
Mchenry

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

21976
21977
41978
51979
61980
131981
61982
141983
31984
151985
101986
51987
21988
51989
31990
11991

Registration details (sample)

MarketIdentifierNameClass / date
USK910924ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE1991-08-28
USK902147ENDOCARDIAL SCREW-IN LEAD MODEL 1028T1990-07-17
USK900512SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS1990-06-25

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