Talia Technology , Ltd.: FDA clearances and approvals
Talia Technology , Ltd. has 6 FDA 510(k) clearances (first 1994, latest 2006), across 2 product codes in 1 review panel. Median 510(k) review time: 48 days.
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 |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | 5 | 5 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Talia Technology , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | HLI | 2006-08-23 | 70 |
| K041290 | RTA MODEL D RETINAL THICKNESS ANALYZER | HLI | 2004-05-24 | 11 |
| K031312 | RTA MODEL D RETINAL THICKNESS ANALYZER | HLI | 2003-05-06 | 12 |
| K000731 | MODIFICATION TO RTA RETINAL THICKNESS ANALYZER | HLI | 2000-03-31 | 25 |
| K964137 | RTA RETINAL THICKNESS ANALYZER | HLI | 1997-02-03 | 111 |
| K930518 | TALIA LASER SLIT | HJO | 1994-01-25 | 358 |
Recalls
openFDA lists no recalls under a recalling firm named Talia Technology , Ltd..
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 Talia Technology , Ltd. have?
Talia Technology , Ltd. has 6 FDA 510(k) clearances (first 1994, latest 2006), across 2 product codes in 1 review panel.
How long does FDA take to clear Talia Technology , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Talia Technology , Ltd.'s cleared 510(k)s is 48 days.
What devices does Talia Technology , Ltd. make?
Its most frequent FDA product codes are HLI (Ophthalmoscope, Ac-Powered, 5); HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 1).
Has Talia Technology , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Talia Technology , Ltd. Related entities may recall under other names.
Next steps
- See all 6 Talia Technology , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HLI, Talia Technology , Ltd.'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.