510k
Database
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531
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1642
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359
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1314
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242
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954
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2166
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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
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274
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2819
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52
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515
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2400
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155
Categories
LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
379
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
299
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System, Imaging, Pulsed Doppler,...
283
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Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
208
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Leo Medical Co., Ltd.
Medical Device Manufacturer
·
CN , Changzhou
Leo Medical Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Leo Medical Co., Ltd.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 20, 2024
Single-use Balloon Dilatation Catheter
K241888
·
FGE
Gastroenterology & Urology
·
175d
Cleared
Jun 14, 2018
Ligation Device
K172985
·
FHN
Gastroenterology & Urology
·
260d
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2
Gastroenterology & Urology
2