Data / Medical devices / Finland / Surgify Medical OY
Surgify Medical OY: FDA-registered device maker in Espoo Uusimaa, Finland, 4 510(k) clearances
Surgify Medical OY is registered with the FDA (registration 3015392173) in Espoo Uusimaa, Finland. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated March 26, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015392173
- Address
- Otakaari 5 I, Espoo Uusimaa, Finland, 02150
- Owner or operator
- Surgify Medical Oy (10090633)
- Roles
- Manufacturer
- First device listed
- April 22, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 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 Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | HBE | Substantially Equivalent | Surgify Medical OY | accessdata.fda.gov |
| June 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 Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | HBE | Substantially Equivalent | Surgify Medical OY | accessdata.fda.gov |
| March 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 Halo (54.000.SEE.H1) | HBE | Substantially Equivalent | Surgify Medical OY | accessdata.fda.gov |
| November 29, 2023 | K232684 | Surgify Halo | HBE | Substantially Equivalent | Surgify Medical OY | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 30, 2026 | 98918 | Class II | Ongoing | Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | accessdata.fda.gov |
Compare with other makers
Updated June 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.