Centervue
Padova Veneto, IT
CENTERVUE appears in FDA device records in Padova Veneto, IT. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Centervue between 2010 and 2025. The busiest year on record is 2010, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243504 | MAIA (AHMACME001) | MYC | Substantially Equivalent | |
| K234076 | iCare ALTIUS CW | NFJ | Substantially Equivalent | |
| K213705 | DRSplus | MYC | Substantially Equivalent | |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | MYC | Substantially Equivalent | |
| K192113 | DRSplus | MYC | Substantially Equivalent | |
| K180526 | EIDON FA | MYC | Substantially Equivalent | |
| K180293 | Retia 2 | MYC | Substantially Equivalent | |
| K153181 | MAIA | MYC | Substantially Equivalent | |
| K150320 | COMPASS | MYC | Substantially Equivalent | |
| K142047 | EIDON | MYC | Substantially Equivalent | |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | HLI | Substantially Equivalent | |
| K101935 | CENTERVUE DIGITAL RETINOGRAPHY SYSTEM | HKI | Substantially Equivalent | |
| K092187 | MAIA, MODEL 1 | HPT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008422902 | 3008422902 | CENTERVUE | via San Marco 9h, Padova Veneto 35129 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain