510k
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Anesthesiology
540
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1663
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362
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1334
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244
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963
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2184
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2043
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126
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97
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8
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466
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963
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433
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274
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2875
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52
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515
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2430
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Changzhou Universal Medical Equipment Co., Ltd.
Medical Device Manufacturer
·
CN , Xinbei District
Changzhou Universal Medical Equipment Co., Ltd. - FDA 510(k) Cleared ...
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Changzhou Universal Medical Equipment Co., Ltd.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 23, 2021
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
K211667
·
LAZ
General & Plastic Surgery
·
114d
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3
General Hospital
2
General & Plastic Surgery
1