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Covidien, Formerly Valleylab, A Division of Tyco

USA · Boulder

✓ 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

12510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 12 510(k)

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

20active device licences

Class II 16Class III 3Class IV 1

29 including historic records

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, 12 510(k), 0 PMA, 2 excluded

Canada20 confirmed, 0 excluded

Manufacturer names merged into this page: VALLEYLAB, A DIV. OF TYCO HEALTHCARE GROUP LP

Same-named companies — This database also contains companies with near-identical names: Covidien, Formerly Valleylab, A Division of Tyco H, VALLEYLAB, A DIV. OF TYCO HEALTHCARE GROUP LP, Valleylab,A Division of Tyco Healthcare Group LP. Company name alone cannot separate their registrations, so the figures below may include either.

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
CA	1321	BISURE LAPAROSCOPIC BIPOLAR FORCEPS	Class II
CA	3827	NONSTERILE, REUSABLE PARTIENT RETURN ELECTRODES	Class II
CA	7271	NONSTERILE, REUSABLE LLETZ ELECTRODES	Class II

Covidien, Formerly Valleylab, A Division of Tyco

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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