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Surgical Devices, A Global Business Unit Covidien

USA · North Haven

✓ 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

56listed device types

Class I 9Class II 47Class III 0

plus 267 registration records and 5 510(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

4active device licences

Class II 3Class III 1

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 States267 registration records, 5 510(k), 0 PMA, 7 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT · Philips India Limited - Diagnostic X-ray Business Unit · Philips India Limited - Ultrasound Business Unit · Philips India Limited - Magnetic Resonance Business Unit · TELEDYNE ANALYTICAL INSTRUMENTS A BUSINESS UNIT OF TELEDYNE INSTR. INC · GP LUMUT (A BUSINESS UNIT OF GREEN PROSPECT SDN BHD)

Same-named companies — This database also contains companies with near-identical names: Philips Global Business Services LLP - Ultrasound Business Unit, Philips India Limited - Diagnostic X-ray Business Unit, Philips India Limited - Sleep & Respiratory Care Business Unit, Philips India Limited - Ultrasound Business Unit. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12008 · K082535

32009 · K093402

12010 · K101444

FDA listed device types

showing 8 of 56

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Posterior Cervical Screw System 1System, Planning, Radiation Therapy Treatment 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1System, X-Ray, Mobile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K101444	AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY	2010-06-14
US	K093402	AUTOSUTURE EEA ORVIL	2009-11-12
US	K091016	COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE	2009-05-04
CA	8339	OXYGEN SENSOR	Class II
CA	66350	OXYGEN MONITORS	Class III
CA	66351	OXYGEN ANALYZERS	Class II

Surgical Devices, A Global Business Unit Covidien

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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