510k
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525
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1613
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356
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1304
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237
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933
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2142
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1999
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126
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91
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453
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429
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272
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2757
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515
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2354
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155
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Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
374
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
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Automated Radiological Image...
275
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System, Imaging, Pulsed Doppler,...
271
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Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
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Abutment, Implant, Dental,...
205
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Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Beijing
Beijing Biosis Healing Biolog Ical Technology Co., Ltd. - FDA 510(k) ...
7 submissions
·
7 cleared
·
Since 2020
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 20, 2021
Medical Gloves
K203622
·
LZA
General Hospital
·
252d
Cleared
Jan 06, 2021
Medical Surgical Gowns
K202844
·
FYA
General Hospital
·
103d
Cleared
Dec 16, 2020
Medical Surgical Mask
K202029
·
FXX
General Hospital
·
147d
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7
General & Plastic Surgery
3
General Hospital
3
Dental
1