510k
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Anesthesiology
525
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1626
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356
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1304
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237
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941
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2148
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2015
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126
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91
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458
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430
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272
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2758
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52
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515
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2356
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155
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Polymer Patient Examination Glove
407
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System, Image Processing,...
374
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357
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351
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Electrosurgical, Cutting &...
297
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Automated Radiological Image...
275
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System, Imaging, Pulsed Doppler,...
271
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Plate, Fixation, Bone
268
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Orthopedic Stereotaxic Instrument
218
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Abutment, Implant, Dental,...
205
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Leadoptik, Inc.
Medical Device Manufacturer
·
US , San Jose , CA
Leadoptik, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Leadoptik, Inc.
Anesthesiology
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 19, 2025
LIA-1 Catheter (542-1)
K251402
·
KTI
Anesthesiology
·
227d
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2
General & Plastic Surgery
1
Anesthesiology
1