Emblation Limited
Stirling Stirling, GB
EMBLATION LIMITED appears in FDA device records in Stirling Stirling, GB. FDA records list 4 510(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 4 510(k) clearances for Emblation Limited between 2018 and 2025. The busiest year on record is 2018, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | NEY | Substantially Equivalent | |
| K240518 | swiftPro™ System | NEY | Substantially Equivalent | |
| K222388 | swiftPro System | NEY | Substantially Equivalent | |
| K181941 | Swift System | NEY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010933564 | 3010933564 | EMBLATION LIMITED | Emblation House, Stirling FK9 4TS GB | 2026 | |
| 3015152398 | 3015152398 | Emblation Inc. | 42 Albion Rd, Lincoln, RI 02865 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