510k
Database
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Anesthesiology
525
Cardiovascular
1630
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
945
General & Plastic Surgery
2151
General Hospital
2020
Hematology
126
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92
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8
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459
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946
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430
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272
Orthopedic
2764
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52
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515
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2356
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Blue Ocean Global
Medical Device Manufacturer
·
US , Miami , FL
Blue Ocean Global - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2026
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Blue Ocean Global
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 20, 2026
Excelsior System
K253291
·
KTT
Orthopedic
·
113d
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