510k
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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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2002
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126
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91
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8
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458
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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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Polymer Patient Examination Glove
404
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374
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357
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351
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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
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Orthopedic Stereotaxic Instrument
218
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Abutment, Implant, Dental,...
205
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Bonraybio Co., Ltd.
Medical Device Manufacturer
·
TW , Taichung
Bonraybio Co., Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2018
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bonraybio Co., Ltd.
Obstetrics & Gynecology
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 31, 2022
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
K221810
·
MQK
Obstetrics & Gynecology
·
131d
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5
Hematology
4
Obstetrics & Gynecology
1