Yama, Inc.: FDA clearances and approvals
Yama, Inc. 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 |
|---|---|---|---|
| LLQ | Cap, Cervical, Contraceptive | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P010043 | PMA | LEA'S SHIELD BARRIER CONTRACEPTIVE | 2002-03-14 |
Recalls
openFDA lists no recalls under a recalling firm named Yama, Inc..
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 Yama, Inc. have?
Yama, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Yama, Inc. make?
Its most frequent FDA product codes are LLQ (Cap, Cervical, Contraceptive, 1).
Has Yama, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Yama, Inc. Related entities may recall under other names.
Next steps
- See all 0 Yama, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLQ, Yama, Inc.'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.