510k
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534
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1649
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359
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1323
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243
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956
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2174
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2038
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126
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97
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8
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462
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954
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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
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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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301
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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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Osang Healthcare Co. , Ltd.
Medical Device Manufacturer
·
KR , Anyang
Osang Healthcare Co. , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osang Healthcare Co. , Ltd.
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 13, 2021
Finetest Lite Blood Glucose Monitoring System
K203562
·
NBW
Chemistry
·
218d
Cleared
Oct 16, 2020
Finetest Lite Smart Blood Glucose Monitoring System
K201396
·
NBW
Chemistry
·
141d
Cleared
Sep 19, 2018
Oh'Care Lite Smart Blood Glucose Monitoring System
K182286
·
NBW
Chemistry
·
27d
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3
Chemistry
3