510k
Database
Specialties
Anesthesiology
542
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1680
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365
Dental
1337
Ear, Nose, Throat
248
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972
General & Plastic Surgery
2194
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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
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515
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2442
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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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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Hunan Vsmile Biotechnology Co., Ltd.
Medical Device Manufacturer
·
CN , Changsha
Hunan Vsmile Biotechnology Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hunan Vsmile Biotechnology Co., Ltd.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 13, 2024
Dental Glass Ceramics Blocks (HT, LT, MT)
K242407
·
EIH
Dental
·
91d
Cleared
Jul 29, 2022
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221242
·
EIH
Dental
·
88d
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Dental
2