Company ยท FI
SURGIFY MEDICAL OY
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (1 in 12 months)
19recalls (19 in 12 months)
19recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 23 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2026 | K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Medical OY, FI | HBE |
| Jun 4, 2025 | K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Medical OY, FI | HBE |
| Mar 13, 2025 | K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1) Surgify Medical OY, FI | HBE |
| Nov 29, 2023 | K232684 | Surgify Halo Surgify Medical OY, FI | HBE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K250380 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K251433 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K251433 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K251433 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | K253627 |