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740
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187
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471
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92
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777
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77
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277
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1098
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System, Imaging, Pulsed Doppler,...
168
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Plate, Fixation, Bone
151
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131
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127
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125
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Automated Radiological Image...
113
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Electrosurgical, Cutting &...
105
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Abutment, Implant, Dental,...
105
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Intervertebral Fusion Device...
96
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Thoracolumbosacral Pedicle Screw...
93
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Augmenix, Inc.
Medical Device Manufacturer
·
US , Waltham , MA
Augmenix, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 2013
5
Total
4
Cleared
1
Denied
FDA 510(k) cleared devices by Augmenix, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 19, 2015
TraceIT Tissue Marker - 3mL
K151998
·
NEU
General & Plastic Surgery
·
30d
Cleared
Jan 23, 2013
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
K121964
·
NEU
General & Plastic Surgery
·
202d
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5
Radiology
3
General & Plastic Surgery
2