510k
Database
Specialties
Anesthesiology
544
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1689
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370
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1347
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250
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979
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2204
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2052
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126
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100
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8
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472
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975
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437
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280
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2977
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52
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515
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2463
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155
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LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
396
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Guangzhou Sonostar Technologies Co., Ltd.
Medical Device Manufacturer
·
CN , Guangzhou
Guangzhou Sonostar Technologies Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Guangzhou Sonostar Technologies Co., Ltd.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 13, 2022
Wireless Probe Type Ultrasound Scanner (Model: CProbe
K211321
·
IYN
Radiology
·
531d
Cleared
Feb 28, 2018
Wireless Probe Type Ultrasound Scanner (Model:UProbe-C
K172750
·
IYO
Radiology
·
169d
Cleared
Oct 27, 2017
C5 Diagnostic Ultrasound System
K171926
·
IYN
Radiology
·
122d
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3
Radiology
3