510k
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557
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1739
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387
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1407
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258
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1007
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2255
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2110
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127
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105
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478
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996
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461
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3101
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518
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2529
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156
Categories
LZA
Polymer Patient Examination Glove
424
LLZ
System, Image Processing,...
406
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Powered Laser Surgical Instrument
370
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Mask, Surgical
361
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Electrosurgical, Cutting &...
316
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System, Imaging, Pulsed Doppler,...
307
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Plate, Fixation, Bone
300
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Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
241
MAX
Intervertebral Fusion Device...
235
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Manufacturers
KR
I-Sens, Inc.
Medical Device Manufacturer
·
KR , Seoul
I-Sens, Inc. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 2008
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
Filters
1
2
Cleared
Feb 10, 2009
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A...
K083468
·
NBW
Chemistry
·
78d
Cleared
Oct 17, 2008
CARESENS BLOOD GLUCOSE MONITORING SYSTEM
K080923
·
NBW
Chemistry
·
198d
1
2
Filters
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27
Chemistry
26
General & Plastic Surgery
1