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SURGIFY MEDICAL OY

FDA Regulatory Profile

SURGIFY MEDICAL OY appears in FDA public data with 19 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2556-2026, Class II) was initiated on April 30, 2026. Its most recent 510(k) clearance was granted on March 26, 2026.

Summary

Total Recalls
19
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2556-2026Class IISurgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessoApril 30, 2026
Z-2557-2026Class IISurgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessorApril 30, 2026
Z-2568-2026Class IISurgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (sApril 30, 2026
Z-2564-2026Class IISurgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & acApril 30, 2026
Z-2569-2026Class IISurgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessApril 30, 2026
Z-2558-2026Class IISurgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & acApril 30, 2026
Z-2562-2026Class IISurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessoApril 30, 2026
Z-2570-2026Class IISurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessorApril 30, 2026
Z-2561-2026Class IISurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessoApril 30, 2026
Z-2571-2026Class IISurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessorApril 30, 2026
Z-2566-2026Class IISurgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessoApril 30, 2026
Z-2565-2026Class IISurgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & acApril 30, 2026
Z-2567-2026Class IISurgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessoApril 30, 2026
Z-2559-2026Class IISurgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & acApril 30, 2026
Z-2573-2026Class IISurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessorApril 30, 2026
Z-2555-2026Class IISurgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & acApril 30, 2026
Z-2560-2026Class IISurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessoApril 30, 2026
Z-2563-2026Class IISurgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessoriApril 30, 2026
Z-2572-2026Class IISurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessorApril 30, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify HMarch 26, 2026
K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify HaJune 4, 2025
K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify March 13, 2025
K232684Surgify HaloNovember 29, 2023

FDA data resources