510k
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Anesthesiology
540
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1672
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362
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1335
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245
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964
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2190
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2043
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126
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97
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8
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466
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965
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433
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274
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2900
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52
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515
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2433
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155
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LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Shenzhen Browiner Tech Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Browiner Tech Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Browiner Tech Co., Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 09, 2024
Digital Radiography System (ManntiX B, ManntiX K)
K240841
·
IZL
Radiology
·
257d
Cleared
Mar 28, 2024
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G,...
K240284
·
IZL
Radiology
·
56d
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Radiology
2