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538
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1656
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360
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1323
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244
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957
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2176
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2039
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126
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97
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8
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462
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959
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433
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274
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2844
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52
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515
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2413
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155
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LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
382
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358
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Powered Laser Surgical Instrument
351
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301
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Suzhou Borage Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Suzhou
Suzhou Borage Medical Technology Co., Ltd. - FDA 510(k) Cleared Devic...
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Suzhou Borage Medical Technology Co., Ltd.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
May 10, 2024
Organic Cotton Tampon
K240708
·
HEB
Obstetrics & Gynecology
·
56d
Cleared
Sep 30, 2022
Unscented Menstrual Tampon
K222046
·
HEB
Obstetrics & Gynecology
·
81d
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2
Obstetrics & Gynecology
2