510k
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740
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187
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471
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92
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398
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777
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77
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277
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120
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1099
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System, Imaging, Pulsed Doppler,...
168
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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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Airxpanders, Inc.
Medical Device Manufacturer
·
US , Palo Alto , CA
Airxpanders, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
2 cleared
·
Since 2016
3
Total
2
Cleared
1
Denied
FDA 510(k) cleared devices by Airxpanders, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 11, 2019
AeroForm Tissue Expander, Smooth
K191138
·
PQN
General & Plastic Surgery
·
72d
Cleared
Apr 03, 2017
AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
K170075
·
PQN
General & Plastic Surgery
·
84d
Not Cleared
Dec 21, 2016
AeroForm Tissue Expander System
DEN150055
·
PQN
General & Plastic Surgery
·
380d
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3
General & Plastic Surgery
3