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545
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1703
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377
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250
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981
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2215
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2065
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126
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100
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8
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474
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980
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439
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282
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2995
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52
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515
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2474
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155
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Polymer Patient Examination Glove
415
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398
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363
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358
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307
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System, Imaging, Pulsed Doppler,...
303
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Plate, Fixation, Bone
287
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Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
225
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Kolo Medical (Suzhou) Co., Ltd.
Medical Device Manufacturer
·
CN , Suzhou
Kolo Medical (Suzhou) Co., Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2022
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kolo Medical (Suzhou) Co., Ltd.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 12, 2022
KOLO Evolution XHD Series Ultrasound Diagnostic System
K221568
·
IYN
Radiology
·
104d
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Radiology
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