510k
Database
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Anesthesiology
132
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568
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163
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313
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68
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287
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513
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371
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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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1291
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Bioventus, LLC
Medical Device Manufacturer
·
US , Durham , NC
Bioventus, LLC - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2017
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Bioventus, LLC
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 16, 2025
StimTrial Neuromodulation System
K243782
·
GZF
Neurology
·
219d
Cleared
Jul 03, 2025
TalisMann Neuromodulation System
K243678
·
GZF
Neurology
·
218d
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5
Orthopedic
2
Neurology
2
General & Plastic Surgery
1