510k
Database
Specialties
Anesthesiology
532
Cardiovascular
1643
Chemistry
359
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1318
Ear, Nose, Throat
242
Gastroenterology & Urology
955
General & Plastic Surgery
2169
General Hospital
2036
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126
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97
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8
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462
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952
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433
Ophthalmic
274
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2828
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52
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515
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2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Inbella Medical, Inc.
Medical Device Manufacturer
·
CA , Richmond Hill
Inbella Medical, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2025
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Inbella Medical, Inc.
General & Plastic Surgery
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 27, 2026
InbellaIgnite RF System
K251435
·
GEI
General & Plastic Surgery
·
264d
Cleared
Oct 15, 2025
InbellaMulti System
K252367
·
GEI
General & Plastic Surgery
·
77d
Cleared
Feb 11, 2025
InbellaBody System
K250200
·
GEI
General & Plastic Surgery
·
19d
Cleared
Jan 03, 2025
Inbella RF System
K243737
·
GEI
General & Plastic Surgery
·
30d
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4
General & Plastic Surgery
4