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Home›USA›Cardio-Pace Medical, Inc.

Cardio-Pace Medical, Inc.

USA · Minneapolis
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
22510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 22 510(k), 9 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
5 including historic records
TWTaiwanTFDA
0valid device licences
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, 22 510(k), 9 PMA, 11 excluded
Manufacturer names merged into this page: PACE MEDICAL INC.
Same-named companies — This database also contains companies with near-identical names: PACE MEDICAL INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Minneapolis

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

11985
11986
41987
11988
11989
21990
31991
11992
11993
11994
42000
22001

Registration details (sample)

MarketIdentifierNameClass / date
USK011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 48252001-09-12
USK012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 42602001-09-04
USK002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V2000-10-18

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