510k
Database
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130
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566
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162
Dental
310
Ear, Nose, Throat
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
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Plate, Fixation, Bone
133
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Orthopedic Stereotaxic Instrument
117
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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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Open Implants, LLC
Medical Device Manufacturer
·
US , Woburn , MA
Open Implants, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2020
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Open Implants, LLC
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 26, 2025
Sherlock
K250967
·
NHA
Dental
·
87d
Cleared
Jun 21, 2022
Sherlock
K220482
·
NHA
Dental
·
123d
Cleared
Nov 30, 2021
Sherlock
K212664
·
NHA
Dental
·
99d
Cleared
Mar 24, 2020
Sherlock
K193335
·
NHA
Dental
·
113d
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4
Dental
4