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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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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
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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
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Earlitec Diagnostics
Medical Device Manufacturer
·
US , Plymouth , MN
Earlitec Diagnostics - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Earlitec Diagnostics
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 05, 2026
EarliPoint Assessment
K253442
·
QPF
Neurology
·
155d
Cleared
Mar 26, 2025
EarliPoint System
K243891
·
QPF
Neurology
·
98d
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2
Neurology
2