510k
Database
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Anesthesiology
541
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1680
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364
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1337
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245
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971
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2191
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2046
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126
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97
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8
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469
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965
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433
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274
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2922
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52
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515
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2436
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155
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LZA
Polymer Patient Examination Glove
408
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System, Image Processing,...
386
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
303
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System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Ontact Health Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Ontact Health Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ontact Health Co., Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 27, 2024
Sonix Health
K240645
·
QIH
Radiology
·
265d
Cleared
Oct 20, 2023
Sonix Health
K230209
·
QIH
Radiology
·
268d
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Radiology
2