MedtechSourcebook

COOK MEDICAL LLC

Contract manufacturer ยท Bloomington, IN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2013Product codes first listed, by year (tallest: 4)2026
FDA registration
3005580113 (openFDA record; or search FDA's registration database)
FEI number
3005580113
Registered for
FDA registration year 2027
Establishment types
Complaint file establishment; Contract manufacturer
Owner or operator
COOK MEDICAL (FDA owner/operator no. 9090900)
Registered address
400 DANIELS WAY, Bloomington, IN 47404
Contract listings
12 device listings, 9 product codes, first listed Nov 14, 2013
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
DQXWire, Guide, CatheterClass IICardiovascularContract manufacturingNov 14, 2013
DREDilator, Vessel, For Percutaneous CatheterizationClass IICardiovascularContract manufacturingNov 13, 2023
DYBIntroducer, CatheterClass IICardiovascularContract manufacturingJun 12, 2023
FEDEndoscopic Access Overtube, Gastroenterology-UrologyClass IIGastroenterology and urologyContract manufacturingMay 20, 2025
FGEStents, Drains And Dilators For The Biliary DuctsClass IIGastroenterology and urologyContract manufacturingMar 7, 2022
GBOCatheter, Nephrostomy, General & Plastic SurgeryClass IGeneral and plastic surgeryContract manufacturingNov 13, 2023
JOLCatheter And Tip, SuctionClass IIGeneral hospitalContract manufacturingFeb 18, 2025
KNTTubes, Gastrointestinal (And Accessories)Class IIGastroenterology and urologyContract manufacturingAug 11, 2025
LJECatheter, NephrostomyUnclassifiedGastroenterology and urologyContract manufacturingNov 13, 2023