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134
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569
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165
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317
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68
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289
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522
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373
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67
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57
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233
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171
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62
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50
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1295
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18
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87
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871
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88
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IYN
System, Imaging, Pulsed Doppler,...
150
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Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
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Abutment, Implant, Dental,...
86
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Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
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Thoracolumbosacral Pedicle Screw...
81
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System, X-ray, Tomography, Computed
79
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Chemtex USA, Inc.
Medical Device Manufacturer
·
US , Fairfield , NJ
Chemtex USA, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Chemtex USA, Inc.
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 12, 2022
Aqua Naina Plus Sterile Saline Solution
K221263
·
LPN
Ophthalmic
·
163d
Cleared
May 26, 2020
Aqua Naina Sterile Saline Solution
K193441
·
LPN
Ophthalmic
·
167d
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Ophthalmic
2