The Female Health Co.: FDA clearances and approvals
The Female Health Co. has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBU | Single-Use Internal Condom | 2 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940033 | PMA | FEMIDOM | 1995-04-14 |
| P910064 | PMA | F C FEMALE CONDOM | 1993-05-07 |
Recalls
openFDA lists no recalls under a recalling firm named The Female Health Co..
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 The Female Health Co. have?
The Female Health Co. has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 1 product code in 1 review panel.
What devices does The Female Health Co. make?
Its most frequent FDA product codes are MBU (Single-Use Internal Condom, 2).
Has The Female Health Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching The Female Health Co. Related entities may recall under other names.
Next steps
- See all 0 The Female Health Co. clearances with predicates and recalls
- Run predicate analysis for product code MBU, The Female Health Co.'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.