510k
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203
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732
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187
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459
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88
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390
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763
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470
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77
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62
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1
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274
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295
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114
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76
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1472
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26
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152
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1079
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93
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IYN
System, Imaging, Pulsed Doppler,...
165
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Plate, Fixation, Bone
150
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Orthopedic Stereotaxic Instrument
129
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Powered Laser Surgical Instrument
123
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System, Image Processing,...
123
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Automated Radiological Image...
109
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Abutment, Implant, Dental,...
104
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Electrosurgical, Cutting &...
104
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Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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A & E Medical Corporation
Medical Device Manufacturer
·
US , Farmingdale , NJ
A & E Medical Corporation - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2018
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by A & E Medical Corporation
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 23, 2020
Sternal Cable System
K193479
·
JDQ
Orthopedic
·
98d
Cleared
Oct 12, 2018
Thorecon Rigid Fixation System
K181607
·
JDQ
Orthopedic
·
115d
Cleared
May 31, 2018
Sternal Cable System
K180582
·
JDQ
Orthopedic
·
87d
Cleared
Feb 12, 2018
Thorecon™ Fixation System
K173579
·
JDQ
Orthopedic
·
84d
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Orthopedic
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