Baxter Bio Science: FDA clearances and approvals
Baxter Bio Science 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 |
|---|---|---|---|
| NBE | Sealant, Polymerizing | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030039 | PMA | COSEAL SURGICAL SEALANT | 2003-12-12 |
Recalls
openFDA lists no recalls under a recalling firm named Baxter Bio Science.
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 Baxter Bio Science have?
Baxter Bio Science has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Baxter Bio Science make?
Its most frequent FDA product codes are NBE (Sealant, Polymerizing, 1).
Has Baxter Bio Science had device recalls?
openFDA lists no recalls under a recalling firm name matching Baxter Bio Science. Related entities may recall under other names.
Next steps
- See all 0 Baxter Bio Science clearances with predicates and recalls
- Run predicate analysis for product code NBE, Baxter Bio Science'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.