510k
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245
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2191
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2046
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97
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469
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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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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
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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O.N. Diagnostics
Medical Device Manufacturer
·
US , Berkeley , CA
O.N. Diagnostics - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - O.N. Diagnostics
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
May 19, 2023
VirtuOst
K220402
·
KGI
Radiology
·
462d
Cleared
Sep 13, 2012
VIRTUOST
K113725
·
KGI
Radiology
·
269d
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2
Radiology
2