510k
Database
Specialties
Anesthesiology
140
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578
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167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
294
General & Plastic Surgery
535
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382
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67
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58
Medical Genetics
0
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234
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173
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67
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52
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1302
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18
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88
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887
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
LNH
System, Nuclear Magnetic...
83
JAK
System, X-ray, Tomography, Computed
79
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Okami Medical
Medical Device Manufacturer
·
US , Aliso Viejo , CA
Okami Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Okami Medical
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 29, 2022
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
K220383
·
KRD
Cardiovascular
·
78d
Cleared
Nov 05, 2020
LOBO Vascular Occlusion System (model LOBO-5)
K203025
·
KRD
Cardiovascular
·
34d
Cleared
Oct 30, 2019
Okami Medical LOBO Vascular Occlusion System
K192083
·
KRD
Cardiovascular
·
89d
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3
Cardiovascular
3