510k
Database
Specialties
Anesthesiology
542
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1680
Chemistry
365
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1338
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249
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975
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2196
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2048
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126
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99
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8
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469
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965
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434
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279
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2940
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52
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515
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2444
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
278
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Onkos Surgical, Inc.
Medical Device Manufacturer
·
US , Parsippany , NJ
Onkos Surgical, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2016
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Onkos Surgical, Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 15, 2025
ELEOS™ Limb Salvage System with NanoCept® Technology
K252920
·
QZZ
Orthopedic
·
33d
Cleared
Jan 30, 2023
My3D® Personalized Pelvic Reconstruction
K223348
·
LPH
Orthopedic
·
89d
Cleared
Feb 23, 2018
ELEOS™ Bipolar Acetabular System
K180130
·
KWY
Orthopedic
·
37d
Cleared
Oct 28, 2016
ELEOS Limb Salvage System
K161520
·
KRO
Orthopedic
·
148d
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Orthopedic
4