510k
Database
Specialties
Anesthesiology
545
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1699
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374
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1351
Ear, Nose, Throat
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
Categories
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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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Sonic Incytes
Medical Device Manufacturer
·
CA , Vancouver
Sonic Incytes - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2020
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sonic Incytes
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 04, 2024
Velacur
K233977
·
IYO
Radiology
·
261d
Cleared
Sep 12, 2023
Velacur
K232459
·
IYO
Radiology
·
28d
Cleared
Apr 20, 2023
Velacur
K223287
·
IYO
Radiology
·
177d
Cleared
Jul 31, 2020
Liver Incytes, Model 1005
K201597
·
IYO
Radiology
·
49d
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4
Radiology
4