510k
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532
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1643
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359
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1318
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242
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955
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2169
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2036
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126
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97
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8
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462
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952
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
299
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
275
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Vivaquant, Inc.
Medical Device Manufacturer
·
US , St. Paul , MN
Vivaquant, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Vivaquant, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 11, 2025
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
K241179
·
QYX
Cardiovascular
·
438d
Cleared
Sep 02, 2020
RX-1 Rhythm Express Remote Cardiac Monitoring System
K200833
·
MLO
Cardiovascular
·
156d
Cleared
Feb 16, 2019
RX-1 Rhythm Express Remote Cardiac Monitoring System
K183704
·
DXH
Cardiovascular
·
47d
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3
Cardiovascular
3