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286
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277
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247
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System, Imaging, Pulsed Doppler,...
237
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233
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Orthopedic Stereotaxic Instrument
197
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Polymer Patient Examination Glove
188
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Abutment, Implant, Dental,...
184
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Intervertebral Fusion Device...
165
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Optimal Imaging Systems, Inc.
Medical Device Manufacturer
·
US , Miami , FL
Optimal Imaging Systems, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2000
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Optimal Imaging Systems, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 11, 2000
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
K000415
·
IYN
Radiology
·
63d
Cleared
Feb 24, 2000
OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM
K000034
·
IYN
Radiology
·
49d
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Radiology
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