510k
Database
Specialties
Anesthesiology
132
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
371
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1291
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
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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S.M.A.I.O
Medical Device Manufacturer
·
FR , Saint-Priest
S.M.A.I.O - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 2020
9
Total
9
Cleared
0
Denied
FDA 510(k) cleared devices by S.M.A.I.O
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
May 30, 2023
KBA3D
K223841
·
LLZ
Radiology
·
159d
Cleared
May 06, 2022
KEOPS Balance Analyzer 3D
K213975
·
LLZ
Radiology
·
137d
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9
Orthopedic
7
Radiology
2