Medical Device Manufacturer · FI , Espoo

Surgify Medical OY - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2023
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Surgify Medical OY Neurology ✕
4 devices
1-4 of 4
Cleared Mar 26, 2026
Surgify Halo (54.085.SHD.U1)
K253627 · HBE
Neurology · 127d
Cleared Jun 04, 2025
Surgify Halo (54.085.SHD.H1)
K251433 · HBE
Neurology · 27d
Cleared Mar 13, 2025
Surgify Halo (54.085.SHD.H1)
K250380 · HBE
Neurology · 30d
Cleared Nov 29, 2023
Surgify Halo
K232684 · HBE
Neurology · 89d
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