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741
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92
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398
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783
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479
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77
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64
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277
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81
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155
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1102
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95
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IYN
System, Imaging, Pulsed Doppler,...
168
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
131
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Powered Laser Surgical Instrument
128
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System, Image Processing,...
126
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Automated Radiological Image...
113
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Abutment, Implant, Dental,...
105
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Electrosurgical, Cutting &...
105
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Intervertebral Fusion Device...
97
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Fastener, Fixation,...
93
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Brightwater Medical
Medical Device Manufacturer
·
US , Dunlap , IL
Brightwater Medical - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Brightwater Medical
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 14, 2019
ConvertX Biliary Stent System
K181669
·
FGE
Gastroenterology & Urology
·
262d
Cleared
Nov 22, 2016
ConvertX Nephroureteral Stent System
K161277
·
FAD
Gastroenterology & Urology
·
200d
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2
Gastroenterology & Urology
2