Aibiomed, Corp.: FDA clearances and approvals
Aibiomed, Corp. 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 |
|---|---|---|---|
| QDF | Parathyroid Autofluorescence Detection Device | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170056 | De Novo | Parathyroid Autofluorescence Detection Device | 2018-11-02 |
Recalls
openFDA lists no recalls under a recalling firm named Aibiomed, Corp..
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 Aibiomed, Corp. have?
Aibiomed, Corp. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Aibiomed, Corp. make?
Its most frequent FDA product codes are QDF (Parathyroid Autofluorescence Detection Device, 1).
Has Aibiomed, Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aibiomed, Corp. Related entities may recall under other names.
Next steps
- See all 0 Aibiomed, Corp. clearances with predicates and recalls
- Run predicate analysis for product code QDF, Aibiomed, Corp.'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.