510k
Database
Specialties
Anesthesiology
386
Cardiovascular
1201
Chemistry
294
Dental
892
Ear, Nose, Throat
165
Gastroenterology & Urology
708
General & Plastic Surgery
1521
General Hospital
904
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109
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78
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1
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392
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663
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285
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176
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2192
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42
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356
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1749
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
253
QIH
Automated Radiological Image...
231
LLZ
System, Image Processing,...
227
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
217
GEI
Electrosurgical, Cutting &...
211
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
149
MAX
Intervertebral Fusion Device...
146
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Cortex Manufacturing, Inc.
Medical Device Manufacturer
·
US , Lake Stevens , WA
Cortex Manufacturing, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2010
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cortex Manufacturing, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 26, 2015
FlexiMarc Marker
K142294
·
IYE
Radiology
·
220d
Cleared
Feb 24, 2010
FLEXIMARC, MODEL CM-0.9-2-10-GG-L
K100267
·
IYE
Radiology
·
26d
Filters
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3
Radiology
2
General & Plastic Surgery
1