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Surgical Devices, A Division of Tyco Healthcare

USA · North Haven

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

261510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 261 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class I 2Class II 20

24 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

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, 261 510(k), 0 PMA, 11 excluded

Brazil22 confirmed, 1 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: KENDALL, A DIVISION OF TYCO HEALTHCARE GROUP LP · UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP, LP · UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP · COVIDIEN, anteriormente registrada como United States Surgical, a division of Tyco Healthc

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141371	SONICISION CORDLESS ULTRASONIC DISSECTOR	2014-08-07
US	K133338	LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX)	2013-12-20
US	K131170	SONICISION STERILIZATION TRAY	2013-08-28
BR	10349000123	CATETER PERITONEAL CURL CATH QUINTON	Class II
BR	10349000339	EQUIPO KANGAROO 924 E ACESSÓRIOS	Class II
BR	10349000383	CATETER TENCKOFF QUINTON E ACESSORIOS	Class II

Surgical Devices, A Division of Tyco Healthcare

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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