510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
Dental
1334
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
963
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2875
Pathology
52
Physical Medicine
515
Radiology
2430
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Okami Medical, Inc.
Medical Device Manufacturer
·
US , Aliso Viejo , CA
Okami Medical, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2023
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Okami Medical, Inc.
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 10, 2026
LOBO Vascular Occlusion System
K260508
·
KRD
Cardiovascular
·
52d
Cleared
Dec 20, 2024
SENDERO MAX Delivery Catheter
K242644
·
DQY
Cardiovascular
·
108d
Cleared
Mar 08, 2024
SENDERO Microcatheter
K240384
·
DQY
Cardiovascular
·
29d
Cleared
Nov 17, 2023
SENDERO Microcatheter
K231600
·
DQY
Cardiovascular
·
169d
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4
Cardiovascular
4