510k
Database
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Anesthesiology
204
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734
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187
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460
Ear, Nose, Throat
90
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390
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767
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473
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77
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62
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1
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274
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296
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114
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76
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1473
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26
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152
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1081
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93
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IYN
System, Imaging, Pulsed Doppler,...
166
HRS
Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
129
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Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
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Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Dunamis, LLC
Medical Device Manufacturer
·
US , Greenville , AL
Dunamis, LLC - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2015
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by Dunamis, LLC
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 14, 2020
Dunamis PunchTac Suture Anchors
K193245
·
MBI
Orthopedic
·
81d
Cleared
Aug 29, 2019
Dunamis Fixation Button System
K191319
·
MBI
Orthopedic
·
106d
Cleared
Jul 06, 2016
Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
K160996
·
MBI
Orthopedic
·
89d
Cleared
Oct 14, 2015
Dunamis Interference Screw
K151220
·
MBI
Orthopedic
·
160d
Filters
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6
Orthopedic
4
General & Plastic Surgery
2