510k
Database
Specialties
Anesthesiology
130
Cardiovascular
565
Chemistry
161
Dental
309
Ear, Nose, Throat
67
Gastroenterology & Urology
286
General & Plastic Surgery
511
General Hospital
368
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
60
Ophthalmic
49
Orthopedic
1285
Pathology
18
Physical Medicine
85
Radiology
865
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
98
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
82
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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Oculogica, Inc.
Medical Device Manufacturer
·
US , New York , NY
Oculogica, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 2018
5
Total
4
Cleared
1
Denied
FDA 510(k) cleared devices by Oculogica, Inc.
Neurology
✕
5
devices
1-5 of 5
Filters
Cleared
Apr 04, 2025
EyeBOX EBX-4.1
K242116
·
QEA
Neurology
·
259d
Cleared
Dec 22, 2021
EyeBOX (Model EBX-4)
K212310
·
QEA
Neurology
·
152d
Cleared
Sep 06, 2020
EyeBOX
K201841
·
QEA
Neurology
·
66d
Cleared
Jul 31, 2019
EyeBOX
K191183
·
QEA
Neurology
·
90d
Not Cleared
Dec 28, 2018
EyeBOX
DEN170091
·
QEA
Neurology
·
371d
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Neurology
5