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COOK, INCORPORATED

USA · Bloomington

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

227listed device types

Class I 85Class II 136Class III 3unclassified 3

plus 791 registration records and 365 510(k), 100 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

103registered devices

Class I 8Class II 95

142 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

62active device licences

Class II 43Class III 5Class IV 14

295 including historic records

TWTaiwanTFDA

90valid device licences

Class I 6Class II 74Class III 10

SGSingaporeHSA SMDR

105device registrations

CLASS B 71CLASS C 13CLASS D 21

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

111active ARTG entries

Class I 1Class III 25IIa 50IIb 15Class Is (sterile) 20

HKHong KongMDACS

116valid listings

Class II 71Class III 19Class IV 26

ILIsraelAMAR

54registrations

RURussiaRoszdravnadzor

50active registrations

Class 2a 29Class 2b 9Class 3 12

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 States791 registration records, 365 510(k), 100 PMA, 32 excluded

Brazil103 confirmed, 15 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada62 confirmed, 11 excluded

Manufacturer names merged into this page: COOK INCORPORATED · Cook Incorporated · COOK, INC. · COOK, INCORPORATED

FDA 510(k) clearances by year

102005

42006

72007

82008

62009

72010

62011

32012

162013

82014

142015

182016

402017

592018

242019

12020

22021

12022

12023

12024

FDA listed device types

showing 8 of 227

Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Endoscopic Guidewire, Gastroenterology-Urology 1Endoscopic Access Overtube, Gastroenterology-Urology 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1Lithotriptor, Biliary Mechanical 1Intrauterine Tamponade Balloon 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233177	Nest VT Vitrification Device	2024-03-08
US	K222254	Gunther Tulip Vena Cava Filter Retrieval Set	2023-05-16
US	K223098	Bakri Essential Postpartum Balloon	2022-10-28
BR	10330710009	AGULHA PARA PUNÇÃO COM ACESSO PERCUTÂNEA RENAL	Class II
BR	10212990008	GUIA METALICO TEFLONADO COOK	Class II
BR	10212990021	DILATADORES PARA TRAQUEOSTOMIA PERCUTANEA	Class II
SA	ME0000006512SFDAA00383	Flexipet® Adjustable Handle Set	—
CA	7255	BLADDER SUSPENSION NEEDLES	Class II
CA	7750	ELECTRODES	Class II
CA	8103	MILLER DOUBLE MUSHROOM BILIARY STENT	Class III