510k
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208
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743
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187
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473
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92
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398
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784
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479
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77
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64
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1
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278
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310
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121
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81
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1484
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26
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155
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1104
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95
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IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
131
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Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
114
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
98
NKB
Thoracolumbosacral Pedicle Screw...
93
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Vivachek Laboratories, Inc.
Medical Device Manufacturer
·
US , Wilmington , DE
Vivachek Laboratories, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Vivachek Laboratories, Inc.
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 19, 2018
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood...
K173140
·
NBW
Chemistry
·
446d
Cleared
Apr 21, 2017
VivaChek Ino Blood Glucose Monitoring System
K160179
·
NBW
Chemistry
·
450d
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Chemistry
2