510k
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411
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1247
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309
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950
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181
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735
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1604
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991
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113
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80
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6
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402
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695
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303
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186
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2261
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43
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377
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1819
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138
Categories
GEX
Powered Laser Surgical Instrument
266
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System, Image Processing,...
255
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Automated Radiological Image...
236
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Electrosurgical, Cutting &...
225
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System, Imaging, Pulsed Doppler,...
225
HRS
Plate, Fixation, Bone
222
OLO
Orthopedic Stereotaxic Instrument
186
NHA
Abutment, Implant, Dental,...
171
NKB
Thoracolumbosacral Pedicle Screw...
154
MAX
Intervertebral Fusion Device...
149
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Aston Medical
Medical Device Manufacturer
·
US , Santa Barbara , CA
Aston Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2011
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aston Medical
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 07, 2014
DUOCENTRIC REVERSED SHOULDER PROSTHESIS
K133462
·
KWS
Orthopedic
·
87d
Cleared
Oct 12, 2012
TREGOR DUAL MOBILITY ACETABULAR SYSTEM
K111981
·
LZO
Orthopedic
·
458d
Cleared
Oct 28, 2011
DUOCENTRIC REVERSED
K103251
·
PHX
Orthopedic
·
359d
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Orthopedic
3