Osmed, Inc.: FDA clearances and approvals
Osmed, 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 |
|---|---|---|---|
| LPG | Material, Dressing, Surgical, Polylactic Acid | 1 | 0 |
Review panels
- Dental (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P800012 | PMA | DRILAC CUBES{TM} | 1983-01-28 |
Recalls
openFDA lists no recalls under a recalling firm named Osmed, 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 Osmed, Inc. have?
Osmed, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Osmed, Inc. make?
Its most frequent FDA product codes are LPG (Material, Dressing, Surgical, Polylactic Acid, 1).
Has Osmed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Osmed, Inc. Related entities may recall under other names.
Next steps
- See all 0 Osmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPG, Osmed, 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.