510k
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204
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739
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187
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465
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91
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394
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771
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475
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77
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64
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1
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277
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300
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116
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78
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1476
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26
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152
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1089
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93
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IYN
System, Imaging, Pulsed Doppler,...
167
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
130
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Powered Laser Surgical Instrument
126
LLZ
System, Image Processing,...
123
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Automated Radiological Image...
110
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Cool Systems, Inc. (Dba Game Ready)
Medical Device Manufacturer
·
US , Concord , CA
Cool Systems, Inc. (Dba Game Ready) - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Cool Systems, Inc. (Dba Game Ready)
Physical Medicine
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 29, 2019
Game Ready GRPro 2.1 System
K192114
·
IRP
Physical Medicine
·
84d
Cleared
Sep 29, 2017
Med4 Elite
K171685
·
IRP
Physical Medicine
·
114d
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2
Physical Medicine
2