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1352
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5022
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3888
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2896
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492
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2616
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4331
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3996
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983
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936
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15
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1963
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1925
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927
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507
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8254
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188
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978
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5349
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1325
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768
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696
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System, Imaging, Pulsed Doppler,...
631
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Electrosurgical, Cutting &...
591
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Powered Laser Surgical Instrument
527
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
485
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Intervertebral Fusion Device...
444
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Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Oticon Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Oticon Corp. - FDA 510(k) Cleared Devices
57 submissions
·
57 cleared
·
Since 1978
57
Total
57
Cleared
0
Denied
FDA 510(k) Regulatory Record - Oticon Corp.
General Hospital
✕
1
devices
1-1 of 1
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Cleared
Mar 04, 1981
EARETTE HEARING AID SEARS #8054
K810379
·
FSD
General Hospital
·
19d
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57
Ear, Nose, Throat
56
General Hospital
1