510k
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553
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1736
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387
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1407
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258
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997
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2244
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2105
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127
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105
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8
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477
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988
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452
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286
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3087
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52
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517
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2517
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156
Categories
LZA
Polymer Patient Examination Glove
423
LLZ
System, Image Processing,...
402
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Powered Laser Surgical Instrument
366
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361
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Electrosurgical, Cutting &...
313
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System, Imaging, Pulsed Doppler,...
306
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Plate, Fixation, Bone
300
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Automated Radiological Image...
277
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Orthopedic Stereotaxic Instrument
238
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Intervertebral Fusion Device...
235
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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) Regulatory Record - 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