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6244
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5219
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3528
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642
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3047
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5153
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2066
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9121
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363
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1103
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5943
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1483
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825
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824
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714
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System, Imaging, Pulsed Doppler,...
646
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Powered Laser Surgical Instrument
634
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System, Nuclear Magnetic...
620
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Prosthesis, Knee,...
553
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Polymer Patient Examination Glove
497
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Thoracolumbosacral Pedicle Screw...
496
MAX
Intervertebral Fusion Device...
495
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510k Database
Manufacturers
US
Omni Intl., Inc.
Medical Device Manufacturer
·
US , Walker , MI
Omni Intl., Inc. - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 1982
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Omni Intl., Inc.
Dental
✕
1
devices
1-1 of 1
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Cleared
Apr 10, 1985
F-SERIES IMPLANT
K850706
·
DZE
Dental
·
47d
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12
General Hospital
5
Neurology
2
Dental
1
Anesthesiology
1
General & Plastic Surgery
1
Physical Medicine
1
Gastroenterology & Urology
1