Coletica S.A.: FDA clearances and approvals
Coletica S.A. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LMF | Agent, Absorbable Hemostatic, Collagen Based | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P930030 | PMA | HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE | 1995-08-15 |
Recalls
openFDA lists no recalls under a recalling firm named Coletica S.A..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Coletica S.A. have?
Coletica S.A. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Coletica S.A. make?
Its most frequent FDA product codes are LMF (Agent, Absorbable Hemostatic, Collagen Based, 1).
Has Coletica S.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching Coletica S.A. Related entities may recall under other names.
Next steps
- See all 0 Coletica S.A. clearances with predicates and recalls
- Run predicate analysis for product code LMF, Coletica S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.