510k
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327
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1055
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267
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791
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147
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617
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1300
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741
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97
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72
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1
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364
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556
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240
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154
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2022
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38
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308
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1561
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129
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Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
207
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System, Imaging, Pulsed Doppler,...
205
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203
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System, Image Processing,...
196
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Electrosurgical, Cutting &...
185
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Orthopedic Stereotaxic Instrument
167
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Abutment, Implant, Dental,...
153
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Intervertebral Fusion Device...
136
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Thoracolumbosacral Pedicle Screw...
132
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Biogenex Laboratories
Medical Device Manufacturer
·
US , Mchenry , IL
Biogenex Laboratories - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 1981
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biogenex Laboratories
Pathology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 08, 2002
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
K012960
·
MXZ
Pathology
·
185d
Cleared
Feb 28, 2002
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
K013148
·
MYA
Pathology
·
161d
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12
Chemistry
9
Pathology
2
Immunology
1