510k
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131
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566
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162
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310
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68
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286
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512
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370
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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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61
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49
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1288
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18
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85
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866
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88
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IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
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Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
MAX
Intervertebral Fusion Device...
83
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Xstrahl, Ltd.
Medical Device Manufacturer
·
GB , Brownhills
Xstrahl, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Xstrahl, Ltd.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 04, 2024
XBeam (v2)
K240671
·
MUJ
Radiology
·
268d
Cleared
Jul 13, 2023
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
K230611
·
JAD
Radiology
·
129d
Cleared
Sep 29, 2017
Photoelectric Therapy System
K172080
·
JAD
Radiology
·
81d
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3
Radiology
3