510k
Database
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142
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581
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167
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326
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68
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297
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539
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384
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67
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58
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234
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174
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69
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53
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1305
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18
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89
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889
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88
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IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
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Orthopedic Stereotaxic Instrument
118
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System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
84
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Gleamer Sas
Medical Device Manufacturer
·
FR , Paris
Gleamer Sas - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Gleamer Sas
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 27, 2025
ChestView US
K241620
·
MYN
Radiology
·
267d
Cleared
Feb 05, 2025
BoneMetrics (US)
K241593
·
QIH
Radiology
·
247d
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2
Radiology
2