Medical Device Manufacturer · FI , Espoo

Surgify Medical OY

3 submissions · 3 cleared · Since 2023
3
Total
3
Cleared
0
Denied

Surgify Medical OY — FDA 510(k) Submissions

Surgify Medical OY has submitted 3 FDA 510(k) premarket notifications since 2023, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Drills, Burrs, Trephines & Accessories (simple, Powered) . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
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)
K251433 · HBE Drills, Burrs, Trephines... · Neurology
Jun 2025 27d
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)
K250380 · HBE Drills, Burrs, Trephines... · Neurology
Mar 2025 30d
Surgify Halo
K232684 · HBE Drills, Burrs, Trephines... · Neurology
Nov 2023 89d
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