510k
Database
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Anesthesiology
545
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1699
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374
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1351
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250
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979
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2213
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2062
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126
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100
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8
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474
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980
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438
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282
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2988
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52
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515
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2468
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155
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LZA
Polymer Patient Examination Glove
414
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System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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358
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
284
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Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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See-Mode Technologies Pte, Ltd.
Medical Device Manufacturer
·
SG , Singapore
See-Mode Technologies Pte, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - See-Mode Technologies Pte, Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 09, 2024
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
K240697
·
QDQ
Radiology
·
179d
Cleared
Sep 16, 2020
AVA (Augmented Vascular Analysis)
K201369
·
LLZ
Radiology
·
117d
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Radiology
2