510k
Database
Specialties
Anesthesiology
135
Cardiovascular
569
Chemistry
165
Dental
318
Ear, Nose, Throat
68
Gastroenterology & Urology
290
General & Plastic Surgery
526
General Hospital
377
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
62
Ophthalmic
51
Orthopedic
1296
Pathology
18
Physical Medicine
87
Radiology
872
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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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Olea Medical S.A.S.
Medical Device Manufacturer
·
FR , La Ciotat
Olea Medical S.A.S. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Olea Medical S.A.S.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 25, 2025
Neurovascular Insight V1.0
K243680
·
LLZ
Radiology
·
269d
Cleared
Jul 23, 2025
Neuro Insight V1.0
K243681
·
LLZ
Radiology
·
236d
Cleared
Jul 06, 2022
Functional MR V1.0
K221426
·
LLZ
Radiology
·
51d
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3
Radiology
3