510k
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Anesthesiology
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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8
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453
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942
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429
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272
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2757
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52
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515
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2354
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155
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LZA
Polymer Patient Examination Glove
403
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System, Image Processing,...
374
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357
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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 & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
May 27, 2021
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable...
K201639
·
GDW
General & Plastic Surgery
·
345d
Cleared
Aug 06, 2020
Disposable Laparoscope Trocar
K201641
·
GCJ
General & Plastic Surgery
·
51d
Cleared
Jul 10, 2020
Disposable Specimen Retrieval Bag
K201243
·
GCJ
General & Plastic Surgery
·
63d
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7
General Hospital
3
General & Plastic Surgery
3
Dental
1