510k
Database
Specialties
Anesthesiology
531
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1642
Chemistry
359
Dental
1314
Ear, Nose, Throat
242
Gastroenterology & Urology
954
General & Plastic Surgery
2166
General Hospital
2031
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126
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97
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8
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462
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951
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433
Ophthalmic
274
Orthopedic
2819
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52
Physical Medicine
515
Radiology
2400
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
379
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
283
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
208
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Shenzhen Osto Technology Company Limited
Medical Device Manufacturer
·
CN , Shenzhen City, Guangdong Province
Shenzhen Osto Technology Company Limited - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2014
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Osto Technology Company Limited
Physical Medicine
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 13, 2021
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
K211942
·
NGX
Physical Medicine
·
173d
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7
Neurology
5
General & Plastic Surgery
1
Physical Medicine
1