510k
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542
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1680
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365
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248
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972
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2194
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2047
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126
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99
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8
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469
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965
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433
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2923
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52
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515
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2442
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155
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LZA
Polymer Patient Examination Glove
409
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388
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358
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356
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305
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System, Imaging, Pulsed Doppler,...
299
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Automated Radiological Image...
276
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Plate, Fixation, Bone
275
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Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Braxx Biotech Co., Ltd.
Medical Device Manufacturer
·
TW , Taipei City
Braxx Biotech Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Braxx Biotech Co., Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 19, 2024
“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
K243045
·
JAQ
Radiology
·
53d
Cleared
Apr 16, 2019
“BRAXX” Esophageal Brachytherapy Applicator
K183332
·
JAQ
Radiology
·
134d
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Radiology
2