510k
Database
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Anesthesiology
544
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1689
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370
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1347
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250
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979
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2204
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2052
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126
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100
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8
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472
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975
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437
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280
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2977
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52
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515
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2463
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
396
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Shenzhen Mecun Medical Supply Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Mecun Medical Supply Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Mecun Medical Supply Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 16, 2024
Disposable Grounding Pad
K231985
·
GEI
General & Plastic Surgery
·
226d
Cleared
Oct 11, 2023
Disposable electrosurgical pencil (MD1000)
K232460
·
GEI
General & Plastic Surgery
·
57d
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3
General & Plastic Surgery
2
Anesthesiology
1