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3006
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8891
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7807
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5231
Ear, Nose, Throat
1703
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4619
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7253
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5924
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1787
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2326
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1641
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1277
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11409
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581
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1407
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7855
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1963
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1091
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1090
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1050
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832
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813
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System, Imaging, Pulsed Doppler,...
773
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Prosthesis, Knee,...
752
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Laparoscope, General & Plastic...
652
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Thoracolumbosacral Pedicle Screw...
622
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Hearing Aid, Air-conduction,...
613
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510k Database
Manufacturers
US
Widex Hearing Aid Co., Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Widex Hearing Aid Co., Inc. - FDA 510(k) Cleared Devices
52 submissions
·
52 cleared
·
Since 1976
52
Total
52
Cleared
0
Denied
52
devices
51-52 of 52
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1
2
3
Cleared
Dec 16, 1976
WIDEX HEARING AID MODEL F8
K761223
·
ESD
Ear, Nose, Throat
·
8d
Cleared
Dec 02, 1976
WIDEX HEARING AID MODEL F7H & F7T
K761103
·
ESD
Ear, Nose, Throat
·
14d
1
2
3
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52
Ear, Nose, Throat
52