510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2176
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
959
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2844
Pathology
52
Physical Medicine
515
Radiology
2413
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Sonomotion, Inc.
Medical Device Manufacturer
·
US , San Mateo , CA
Sonomotion, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
2 cleared
·
Since 2024
Official Website
3
Total
2
Cleared
1
Denied
FDA 510(k) Regulatory Record - Sonomotion, Inc.
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 29, 2026
Break Wave
K261086
·
LNS
Gastroenterology & Urology
·
28d
Cleared
CT
Jan 12, 2026
Break Wave
K252913
·
LNS
Gastroenterology & Urology
·
122d
Not Cleared
Oct 30, 2024
Stone Clear (SC-LP9-01)
DEN230082
·
QNA
Gastroenterology & Urology
·
328d
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3
Gastroenterology & Urology
3