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Cardiac Pacemakers, Inc.

USA · Mchenry

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Singapore — 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

80510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 80 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 2

33 including historic records

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

57device registrations

CLASS B 1CLASS C 3CLASS D 48D WITH MEDICINAL PRODUCT 5

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, 80 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: CARDIAC PACEMAKERS INCORPORATED (UMA SUBSIDIÁRIA DA GUIDANT CORPORATION, UMA SUBSIDIÁRIA D · CARDIAC PACEMAKERS INC., A SUBSIDIARY OF BOSTON SCIENTIFIC CORPORATION · CARDIAC PACEMAKERS INCORPORATED (USA) (UMA SUBSIDIÁRIA DA BOSTON SCIENTIFIC CORPORATION) · CARDIAC PACEMAKERS INCORPORATED (UMA SUBDISIÁRIA DA GUIDANT CORPORATION/UMA SUBSIDIÁRIA DA

Registration details (sample)

Market	Identifier	Name	Class / date
US	K093969	ACUITY BREAK-AWAY GUIDE CATHETER	2010-03-05
US	K080154	ACUITY UNIVERSAL CUTTER	2008-03-20
US	K934727	REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER	1994-01-10
BR	10341350596	FERRAMENTA DE FIXAÇÃO PARA ELETRODOS	Class I
BR	10341359001	VEIN PICK	Class II
BR	10341351020	Instrumento de Corte Universal Acuity	Class I

Cardiac Pacemakers, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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