510k
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Anesthesiology
641
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1951
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422
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1573
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279
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1108
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2475
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2287
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142
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112
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11
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516
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1099
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511
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330
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3379
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57
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556
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2773
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165
Categories
LLZ
System, Image Processing,...
452
LZA
Polymer Patient Examination Glove
434
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Powered Laser Surgical Instrument
403
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Mask, Surgical
384
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Electrosurgical, Cutting &...
358
IYN
System, Imaging, Pulsed Doppler,...
331
HRS
Plate, Fixation, Bone
316
QIH
Automated Radiological Image...
284
OLO
Orthopedic Stereotaxic Instrument
258
MAX
Intervertebral Fusion Device...
257
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Manufacturers
US
Omnia Spa
Medical Device Manufacturer
·
US , Carmel , IN
Omnia Spa - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2011
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Omnia Spa
General Hospital
✕
1
devices
1-1 of 1
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Cleared
Jun 23, 2011
SURGICAL PROCEDURE PACKS
K110724
·
FYA
General Hospital
·
99d
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3
General & Plastic Surgery
2
General Hospital
1