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Anesthesiology
1355
Cardiovascular
5036
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3958
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2897
Ear, Nose, Throat
516
Gastroenterology & Urology
2657
General & Plastic Surgery
4415
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4000
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984
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1052
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15
Microbiology
1996
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1930
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946
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541
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8263
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189
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978
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5352
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1325
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LLZ
System, Image Processing,...
768
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Plate, Fixation, Bone
696
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System, Imaging, Pulsed Doppler,...
631
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Electrosurgical, Cutting &...
601
GEX
Powered Laser Surgical Instrument
527
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
444
NKB
Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Hearing Aid Co.
Medical Device Manufacturer
·
US , Mchenry , IL
Hearing Aid Co. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1980
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hearing Aid Co.
Ear, Nose, Throat
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 18, 1991
CUSTOM ITE HEARING AID
K905784
·
ESD
Ear, Nose, Throat
·
90d
Cleared
Apr 12, 1988
HEARING AID (ALL-IN-THE-EAR)
K881296
·
ESD
Ear, Nose, Throat
·
15d
Cleared
Oct 10, 1980
WIDEX HEARING AID #'S A18+T & A18+H
K802306
·
ESD
Ear, Nose, Throat
·
17d
Cleared
Oct 10, 1980
WIDEX HEARING AID #'S A12+T & A12+H
K802307
·
ESD
Ear, Nose, Throat
·
17d
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Ear, Nose, Throat
4