Cook Medical Incorporated: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Cook Medical Incorporated”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Cook Medical, based on public ownership records.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 1 | 0 |
| NIN | Stent, Renal | 1 | 0 |
Review panels
- Cardiovascular (2)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P140016 | PMA | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT | 2015-09-15 |
| P100028 | PMA | FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM | 2011-01-14 |
Recalls
53 product recalls in 8 recall events; 5 initiated in the last five years. Most recent: 2025-09-18.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cook, Inc. (190 510(k)s)
- Cook Incorporated (174 510(k)s)
- Cook Urological, Inc. (104 510(k)s)
- Cook Ob/Gyn (43 510(k)s)
- Cook Pacemaker Corp. (34 510(k)s)
- Cook Ireland, Ltd. (33 510(k)s)
- Cook Biotech, Inc. (31 510(k)s)
- Cook Biotech Incorporated (16 510(k)s)
- Cook Vascular, Inc. (12 510(k)s)
- Cook Endoscopy (4 510(k)s)
- Cook Biotech Incorprated (4 510(k)s)
- Cook Advanced Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cook Medical Incorporated?
FDA lists 0 510(k) clearances under the applicant name “Cook Medical Incorporated”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Cook Medical Incorporated?
The most frequent FDA product codes under this applicant name are MIH (System, Endovascular Graft, Aortic Aneurysm Treatment, 1); NIN (Stent, Renal, 1).
Next steps
- See all 0 Cook Medical Incorporated clearances with predicates and recalls
- Run predicate analysis for product code MIH, Cook Medical Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.