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Cook Medical Incorporated

USA · Bloomington

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Israel — 6 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

82listed device types

Class I 12Class II 62Class III 7unclassified 1

plus 195 registration records and 136 510(k), 24 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

39registered devices

Class I 3Class II 36

57 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

32active device licences

Class II 16Class III 16

79 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

58device registrations

CLASS B 27CLASS C 13CLASS D 18

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States195 registration records, 136 510(k), 24 PMA, 28 excluded

Brazil39 confirmed, 10 excluded

Saudi Arabia3 confirmed, 1 excluded

Canada32 confirmed, 11 excluded

Manufacturer names merged into this page: Cook Medical EUDC GmbH · COOK MEDICAL LLC · Wilson-Cook Medical Inc. · WILSON-COOK MEDICAL, INC. · WILSON COOK MEDICAL, INC · WILSON-COOK MEDICAL INC

FDA 510(k) clearances by year

42002

42003

72004

22005

12007

12010

12011

32012

12013

22014

22016

102017

102018

82019

42020

12021

22022

12024

22025

12026

FDA listed device types

showing 8 of 82

Needle, Assisted Reproduction 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Injection Needle, Gastroenterology-Urology 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Prosthesis, Esophageal 1Media, Reproductive 1Endoscopic Access Overtube, Gastroenterology-Urology 1Endoscopic Guidewire, Gastroenterology-Urology 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253302	Hemospray Endoscopic Hemostat (HEMO-[X])	2026-06-02
US	K251104	SureTome SW Sphincterotome with DomeTip	2025-09-29
US	K243568	Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord	2025-01-17
BR	10212990040	MANOMETRO DE INSUFLACAO PARA BALAO ENDOSCOPICO	Class II
BR	10212990044	CONJUNTO PARA DRENAGEM NASO-BILIAR	Class II
BR	10212990192	ACESSORIOS PARA GASTROSTOMIA	Class II
SA	ME0000018822SFDAA00001	SAVARY-GILLIARD WIRE GUIDE	—
SA	ME0000018869SFDAA00001	Soehendra Lithotriptor Handle	—
CA	625	ESOPHAGEAL PROSTHESIS SET	Class III
CA	628	ESOPHAGEAL PROSTHESIS	Class III
CA	2181	PANCREATIC STENT	Class III

Cook Medical Incorporated

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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