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Cook Biotech Incorporated

USA · West Lafayette

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

19listed device types

Class I 3Class II 15Class III 0unclassified 1

plus 43 registration records and 51 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

12 including historic records

TWTaiwanTFDA

11valid device licences

Class II 11

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Business type not stated 1Import 1

AUAustraliaTGA ARTG

6active ARTG entries

Class III 6

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

4registrations

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 States43 registration records, 51 510(k), 0 PMA, 33 excluded

Brazil0 confirmed, 15 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 11 excluded

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

FDA 510(k) clearances by year

22000

42002

22003

12004

32005

52006

22007

22008

22009

12011

12012

32013

32014

42015

52016

42017

12018

12019

12020

12024

FDA listed device types

showing 8 of 19

Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) 1Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 1Prosthesis, Eyelid Spacer/Graft, Biologic 1Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed 1Barrier, Animal Source, Intraoral 1Dura Substitute 1Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery 1Mesh, Surgical, Collagen, Large Abdominal Wall Defects 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232646	Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)	2024-05-24
US	K201000	Biodesign Staple Line Reinforcement	2020-07-13
US	K191696	Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft	2019-12-27

Cook Biotech 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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