510k
Database
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Anesthesiology
130
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564
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161
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309
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67
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286
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511
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368
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67
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56
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0
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232
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163
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60
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49
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1285
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18
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85
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865
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88
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IYN
System, Imaging, Pulsed Doppler,...
150
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Plate, Fixation, Bone
133
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
98
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
82
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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Surgify Medical OY
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) cleared devices by Surgify Medical OY
Neurology
✕
4
devices
1-4 of 4
Filters
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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4
Neurology
4