Eagle Vision, Inc.: FDA clearances and approvals
Eagle Vision, Inc. has 7 FDA 510(k) clearances (first 1988, latest 2006), across 2 product codes in 1 review panel. Median 510(k) review time: 81 days. openFDA lists 4 product recalls by a recalling firm named Eagle Vision, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZU | Plug, Punctum | 5 | 5 |
| OKS | Lacrimal Stents And Intubation Sets | 2 | 2 |
Review panels
- Ophthalmic (7)
Most recent Eagle Vision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053333 | EAGLEVISION GELLANSERTS, MODEL REF 0040 | LZU | 2006-05-02 | 152 |
| K030353 | MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS | OKS | 2003-04-25 | 81 |
| K991130 | FLEXPLUG | LZU | 1999-04-20 | 18 |
| K905427 | EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG | LZU | 1991-06-06 | 184 |
| K890919 | TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT | LZU | 1989-05-16 | 82 |
| K890920 | EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE | LZU | 1989-04-11 | 47 |
| K883233 | EV MONOCANALICULAR STENT (TM) | OKS | 1988-08-22 | 21 |
Recalls
4 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-04-12.
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 Eagle Vision, Inc. have?
Eagle Vision, Inc. has 7 FDA 510(k) clearances (first 1988, latest 2006), across 2 product codes in 1 review panel.
How long does FDA take to clear Eagle Vision, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Eagle Vision, Inc.'s cleared 510(k)s is 81 days.
What devices does Eagle Vision, Inc. make?
Its most frequent FDA product codes are LZU (Plug, Punctum, 5); OKS (Lacrimal Stents And Intubation Sets, 2).
Has Eagle Vision, Inc. had device recalls?
openFDA lists 4 product recalls in 1 recall event by a recalling firm whose name matches Eagle Vision, Inc; the most recent began 2006-04-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Eagle Vision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZU, Eagle Vision, 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.