Palliare
Oceanside, CA, US
PALLIARE appears in FDA device records in Oceanside, CA. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. 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 Palliare between 2020 and 2024. The busiest year on record is 2020, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 2 |
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232902 | EVA15 insufflator | HIF | Substantially Equivalent | |
| K230474 | EVA5 Insufflator | FCX | Substantially Equivalent | |
| K222901 | EVA15 insufflator | HIF | Substantially Equivalent | |
| K202922 | END 200 Endoscopic Tubeset | FCX | Substantially Equivalent | |
| K202799 | EVA15 | HIF | Substantially Equivalent | |
| K193520 | EVA 15 Insufflator | HIF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017590240 | 3017590240 | PALLIARE | Palliare, Galway Business Park, Galway Galway(County) H91P2DK IE | 2026 | |
| 3017565103 | 3017565103 | PALLIARE INC | 301 Mission Ave #211, Oceanside, CA 92054 US | 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