# Cook Medical Incorporated

- Location (FDA's records): Bjaeverskov
- FDA decisions: 3 (2011–2024): 1 510(k) clearance and 2 original PMA approvals
- Names in FDA's records: Cook Medical Incorporated (2); Cook Medical (1)
- Product codes: MIH (1), DYB (1), NIN (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Recent decisions
- K240589: Micropuncture Introducer Sets; Micropuncture Pedal Access Sets (Mar 25, 2024)
- P140016: Zenith Alpha Thoracic Endovascular Graft (Sep 15, 2015)
- P100028: Formula Balloon-Expandable Renal Stent System (Jan 14, 2011)

Source page: https://510kreport.com/company/cook-medical