510k
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Anesthesiology
538
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1656
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360
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1323
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244
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957
General & Plastic Surgery
2176
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2039
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126
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97
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8
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462
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959
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433
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274
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2844
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52
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515
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2413
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155
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LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
382
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358
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Powered Laser Surgical Instrument
351
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301
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Betters(Suzhou) Medical Co., Ltd.
Medical Device Manufacturer
·
CN , Suzhou
Betters(Suzhou) Medical Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Betters(Suzhou) Medical Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 13, 2023
Microwave Ablation System (BD-GT)
K232240
·
NEY
General & Plastic Surgery
·
108d
Cleared
Nov 13, 2023
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815,...
K232241
·
NEY
General & Plastic Surgery
·
108d
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2
General & Plastic Surgery
2