510k
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550
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1722
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385
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1379
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252
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985
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2224
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2088
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127
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101
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8
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474
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441
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283
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3050
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52
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515
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2497
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155
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Polymer Patient Examination Glove
416
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401
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363
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359
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310
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System, Imaging, Pulsed Doppler,...
304
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Plate, Fixation, Bone
297
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Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Siemens Medical Soultions USA, Inc.
Medical Device Manufacturer
·
US , Hiffman Estates , IL
Siemens Medical Soultions USA, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Siemens Medical Soultions USA, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 13, 2023
Chondral Quant
K231351
·
LLZ
Radiology
·
65d
Cleared
Mar 25, 2020
syngo.CT Cardiac Planning
K200515
·
JAK
Radiology
·
23d
Cleared
Jul 19, 2019
syngo.via MI Workflows VB40A, Scenium
K191309
·
LLZ
Radiology
·
66d
Filters
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3
Radiology
3