Addition Technology: FDA clearances and approvals
Addition Technology 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 |
|---|---|---|---|
| LQE | Implant, Corneal, Refractive | 1 | 0 |
Review panels
- Ophthalmic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P980031 | PMA | INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS | 1999-04-09 |
Recalls
openFDA lists no recalls under a recalling firm named Addition Technology.
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 Addition Technology have?
Addition Technology has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Addition Technology make?
Its most frequent FDA product codes are LQE (Implant, Corneal, Refractive, 1).
Has Addition Technology had device recalls?
openFDA lists no recalls under a recalling firm name matching Addition Technology. Related entities may recall under other names.
Next steps
- See all 0 Addition Technology clearances with predicates and recalls
- Run predicate analysis for product code LQE, Addition Technology'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.