ClaroNav Inc.
Toronto Ontario, CA
ClaroNav Inc. appears in FDA device records in Toronto Ontario, CA. FDA records list 6 510(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 6 510(k) clearances for ClaroNav Inc. between 2016 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | PGW | Substantially Equivalent | |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | HAW | Substantially Equivalent | |
| K233563 | Navident | PLV | Substantially Equivalent | |
| K210947 | Navident | PLV | Substantially Equivalent | |
| K163439 | NaviENT | HAW | Substantially Equivalent | |
| K161406 | Navident | PLV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011874573 | 3011874573 | ClaroNav Inc. | 1140 Sheppard Ave. West, Toronto Ontario M3K 2A2 CA | 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