Powerful Medical, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Powerful Medical, Inc.”, plus 1 De Novo decision, across 1 product code. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SHS | 1 | 0 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250044 | De Novo | 2026-09-03 |
Recalls
openFDA lists no recalls under a recalling firm named Powerful Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Powerful Medical, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Powerful Medical, Inc.”, plus 1 De Novo decision, across 1 product code. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Powerful Medical, Inc.?
The most frequent FDA product codes under this applicant name are SHS (device, 1).
Next steps
- See all 0 Powerful Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SHS, Powerful Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.