510k
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Anesthesiology
542
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1680
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365
Dental
1338
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249
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975
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2196
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2048
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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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434
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279
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2940
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52
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515
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2444
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
388
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358
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Powered Laser Surgical Instrument
356
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306
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
278
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Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Yilink (Tianjin) Biotechnology Co., Ltd.
Medical Device Manufacturer
·
CN , Tianjin
Yilink (Tianjin) Biotechnology Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Yilink (Tianjin) Biotechnology Co., Ltd.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 10, 2024
Dental porcelain powder
K242400
·
EIH
Dental
·
58d
Cleared
Feb 10, 2023
Glass Ceramics
K222513
·
EIH
Dental
·
175d
Cleared
Nov 14, 2022
Zirconia Block
K222520
·
EIH
Dental
·
87d
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3
Dental
3