510k
Database
Specialties
Anesthesiology
134
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569
Chemistry
165
Dental
318
Ear, Nose, Throat
68
Gastroenterology & Urology
290
General & Plastic Surgery
526
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377
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
234
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173
Obstetrics & Gynecology
62
Ophthalmic
51
Orthopedic
1295
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18
Physical Medicine
87
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872
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Genalyte, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Genalyte, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Genalyte, Inc.
Immunology
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 25, 2019
Maverick RNP Assay and Maverick Diagnostic System
K191085
·
LKO
Immunology
·
184d
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2
Immunology
1
Chemistry
1