510k
Database
Specialties
Anesthesiology
556
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1738
Chemistry
387
Dental
1407
Ear, Nose, Throat
258
Gastroenterology & Urology
1006
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2255
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2110
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127
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105
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8
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478
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996
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461
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287
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3097
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52
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518
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2529
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156
Categories
LZA
Polymer Patient Examination Glove
424
LLZ
System, Image Processing,...
406
GEX
Powered Laser Surgical Instrument
370
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Mask, Surgical
361
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Electrosurgical, Cutting &...
316
IYN
System, Imaging, Pulsed Doppler,...
307
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
241
MAX
Intervertebral Fusion Device...
235
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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.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 18, 1983
OMNIPROBE ELECTRICAL NERVE STIMULATOR
K831147
·
GZJ
Neurology
·
101d
Cleared
Jun 16, 1982
OMNI TENS
K821523
·
GZJ
Neurology
·
26d
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12
General Hospital
5
Neurology
2
Physical Medicine
1
Gastroenterology & Urology
1
Dental
1
Anesthesiology
1
General & Plastic Surgery
1