510k
Database
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Anesthesiology
542
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1683
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370
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1341
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250
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978
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2199
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2052
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126
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99
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8
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472
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967
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436
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279
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2952
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52
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515
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2455
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
228
MAX
Intervertebral Fusion Device...
220
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Sonex Health
Medical Device Manufacturer
·
US , Eagan , MN
Sonex Health - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sonex Health
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 29, 2025
UltraGuideCTR® image guided soft tissue release system
K252594
·
HRX
Orthopedic
·
45d
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Orthopedic
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