510k
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204
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734
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187
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459
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89
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390
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766
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472
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77
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62
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1
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274
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295
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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
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
129
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Powered Laser Surgical Instrument
125
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System, Image Processing,...
123
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Automated Radiological Image...
109
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Electrosurgical, Cutting &...
105
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Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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DEKA Research & Development
Medical Device Manufacturer
·
US , Manchester , NH
DEKA Research & Development - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by DEKA Research & Development
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 21, 2020
Unity Subcutaneous Infusion System for Remodulin
K191313
·
QJY
General Hospital
·
282d
Cleared
May 06, 2019
Unity Subcutaneous Delivery System for Remodulin
K190182
·
FRN
General Hospital
·
94d
Cleared
Oct 03, 2016
Volumetric Infusion Controller
K153760
·
LDR
General Hospital
·
278d
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3
General Hospital
3