510(k) submissions
Filtered by Unclassified · showing 1–7 of 7
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc.United States | — | Class 2 | 2026-06-05 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLCUnited States | — | Class 2 | 2026-06-02 |
| K253803 | MILAN System | Lumenis Be, Ltd.Israel | — | Class 2 | 2026-06-02 |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources CorporationUnited States | — | Class 2 | 2025-10-31 |
| K252576 | Legend X Platform | Pollogen, Ltd.Israel | — | Class 2 | 2025-09-12 |
| K243176 | BLESSING System | Cellah Medical Co., Ltd.Korea, Republic of | — | Class 2 | 2025-05-16 |
| K240311 | JETT Medical II | Compex, Spol, S.R.O.Czechia | — | Class 2 | 2025-01-22 |