510k
Database
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Anesthesiology
534
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1644
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359
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1323
Ear, Nose, Throat
243
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956
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2174
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2037
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126
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97
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8
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462
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952
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Shandong Hongxin Chemicals Co., Ltd.
Medical Device Manufacturer
·
CN , Beijing
Shandong Hongxin Chemicals Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shandong Hongxin Chemicals Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 26, 2021
Synthetic Nitrile Examination Gloves
K212488
·
LYZ
General Hospital
·
109d
Cleared
Dec 10, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K122828
·
LYZ
General Hospital
·
84d
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2
General Hospital
2