Amferia AB: FDA clearances and approvals
Amferia AB has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SHA | Solid Wound Dressing With Permanently Bound Antimicrobial Agent | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250006 | De Novo | Solid Wound Dressing With Permanently Bound Antimicrobial Agent | 2026-02-06 |
Recalls
openFDA lists no recalls under a recalling firm named Amferia AB.
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 Amferia AB have?
Amferia AB has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Amferia AB make?
Its most frequent FDA product codes are SHA (Solid Wound Dressing With Permanently Bound Antimicrobial Agent, 1).
Has Amferia AB had device recalls?
openFDA lists no recalls under a recalling firm name matching Amferia AB. Related entities may recall under other names.
Next steps
- See all 0 Amferia AB clearances with predicates and recalls
- Run predicate analysis for product code SHA, Amferia AB'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.