510k
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Anesthesiology
541
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1672
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364
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1336
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245
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969
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2190
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2046
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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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2912
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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
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System, Image Processing,...
386
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358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
302
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System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Huizhou Xinyi Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Huizhou
Huizhou Xinyi Technology Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Huizhou Xinyi Technology Co., Ltd.
Physical Medicine
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 02, 2024
Air compression leg massager
K240981
·
IRP
Physical Medicine
·
114d
Cleared
Dec 08, 2022
YY-A02-B Overlapped Compression Therapy
K221862
·
IRP
Physical Medicine
·
164d
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Physical Medicine
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