510k
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Anesthesiology
557
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1740
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387
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1410
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258
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1008
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2258
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2112
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127
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105
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8
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478
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998
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461
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289
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3106
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52
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519
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2530
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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
371
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Mask, Surgical
361
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Electrosurgical, Cutting &...
318
IYN
System, Imaging, Pulsed Doppler,...
307
HRS
Plate, Fixation, Bone
301
QIH
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
26
devices
26-26 of 26
Filters
1
2
Cleared
Oct 17, 2008
CARESENS BLOOD GLUCOSE MONITORING SYSTEM
K080923
·
NBW
Chemistry
·
198d
1
2
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27
Chemistry
26
General & Plastic Surgery
1