510k
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Anesthesiology
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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953
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2165
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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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950
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433
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274
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2812
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52
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515
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2386
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
378
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
298
IYN
System, Imaging, Pulsed Doppler,...
280
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
224
MAX
Intervertebral Fusion Device...
208
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Suzhou Zenith Vascular SciTech Limited
Medical Device Manufacturer
·
CN , Suzhou
Suzhou Zenith Vascular SciTech Limited - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Suzhou Zenith Vascular SciTech Limited
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 16, 2026
Zenith Micro Guidewire
K252317
·
MOF
Neurology
·
265d
Cleared
Jul 30, 2025
Micro Catheter
K243534
·
KRA
Neurology
·
257d
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2
Neurology
2