510k
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130
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565
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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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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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Stephanix
Medical Device Manufacturer
·
FR , La Ricamarie
Stephanix - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Stephanix
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 07, 2022
D²RS and D²RS 9090
K221335
·
OWB
Radiology
·
29d
Cleared
Dec 23, 2021
D²RS and D²RS 9090
K213479
·
OWB
Radiology
·
55d
Cleared
Nov 03, 2021
MOVIX DReamy
K212515
·
IZL
Radiology
·
85d
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3
Radiology
3