510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
General & Plastic Surgery
2194
General Hospital
2047
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126
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99
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8
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469
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965
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433
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275
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2923
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52
Physical Medicine
515
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2442
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Avatar Medical
Medical Device Manufacturer
·
FR , Paris
Avatar Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Avatar Medical
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 20, 2025
brAIn™ Shoulder Positioning
K252665
·
QIH
Radiology
·
56d
Cleared
Mar 20, 2025
brAIn™ Shoulder Positioning
K243292
·
LLZ
Radiology
·
153d
Cleared
May 24, 2023
Avatar Medical Software V1
K222035
·
LLZ
Radiology
·
317d
Filters
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3
Radiology
3