510k
Database
Specialties
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198
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722
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185
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450
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86
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383
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751
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462
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74
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61
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1
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271
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288
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112
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75
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1464
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26
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146
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1069
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93
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IYN
System, Imaging, Pulsed Doppler,...
162
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Plate, Fixation, Bone
150
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Orthopedic Stereotaxic Instrument
128
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Powered Laser Surgical Instrument
122
LLZ
System, Image Processing,...
122
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Automated Radiological Image...
107
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Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Arlington Scientific, Inc. (Asi)
Medical Device Manufacturer
·
US , Springville , UT
Arlington Scientific, Inc. (Asi) - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Arlington Scientific, Inc. (Asi)
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 21, 2020
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI...
K201438
·
GMQ
Microbiology
·
142d
Cleared
Nov 30, 2018
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
K182391
·
GMQ
Microbiology
·
87d
Cleared
Jun 14, 2018
ASI Evolution
K173376
·
GMQ
Microbiology
·
227d
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3
Microbiology
3