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COVIDIEN LIMITED

USA · Mansfield

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

225listed device types

Class I 54Class II 163Class III 4unclassified 4

plus 1,172 registration records and 224 510(k), 19 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

134registered devices

Class I 20Class II 114

216 including historic records

SASaudi ArabiaSFDA

48registered imported devices

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

CACanadaMDALL

135active device licences

Class II 99Class III 33Class IV 3

544 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 States1,172 registration records, 224 510(k), 19 PMA, 19 excluded

Brazil134 confirmed, 11 excluded

Saudi Arabia48 confirmed, 0 excluded

Canada135 confirmed, 3 excluded

Manufacturer names merged into this page: Covidien · Covidien llc · Covidien LLC · COVIDIEN · COVIDIEN LLC · COVIDIEN LIMITED

FDA 510(k) clearances by year

32008

62009

52010

42011

132012

142013

242014

332015

262016

112017

172018

72019

162020

72021

142022

92023

62024

52025

42026

FDA listed device types

showing 8 of 225

Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1Device, Monitoring, Intracranial Pressure 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1Continuous, Ventilator, Home Use 1System, Ablation, Microwave And Accessories 1Dialysis Administration Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260907	BIS Advance pEEG Module	2026-08-13
US	K253527	Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)	2026-07-01
US	K253984	Instrument Exit Point on Touch Surgery Aide	2026-06-04
BR	10349000014	THORACOPORT CANULA E TROCARTE DESCARTAVEL AUTOSUTURE	Class II
BR	10349000868	Shiley Cânula de traqueostomia neonatal e pediátrica com cuff TaperGua	Class II
BR	10349000869	Shiley Cânula de traqueostomia neonatal e pediátrica sem cuff	Class II
SA	ME0000001197SFDAA00001	TruClear	—
SA	ME0000001197SFDAA00005	Kendall	—
CA	95208	NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM	Class III
CA	96343	SHILEY LARYNGEAL MASK	Class II
CA	98167	LIGASURE MARYLAND JAW SEALERDIVIDER ONE-STEP SEALING	Class II

COVIDIEN LIMITED

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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