510k
Database
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Anesthesiology
542
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1685
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370
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1345
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250
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979
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2202
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2052
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126
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100
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8
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472
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975
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436
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279
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2970
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52
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515
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2458
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155
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Polymer Patient Examination Glove
409
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System, Image Processing,...
391
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358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
222
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Limbus Ai, Inc.
Medical Device Manufacturer
·
CA , Regina
Limbus Ai, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Limbus Ai, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 09, 2024
Limbus Contour
K241837
·
QKB
Radiology
·
106d
Cleared
Apr 07, 2023
Limbus Contour
K230575
·
LLZ
Radiology
·
37d
Cleared
Aug 13, 2020
Limbus Contour
K201232
·
LLZ
Radiology
·
98d
Filters
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3
Radiology
3