510k
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Anesthesiology
3779
Cardiovascular
10099
Chemistry
8815
Dental
6180
Ear, Nose, Throat
2016
Gastroenterology & Urology
5373
General & Plastic Surgery
8539
General Hospital
6908
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2056
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2629
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16
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4954
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2975
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1902
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1485
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12533
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639
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1638
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8427
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2194
Categories
GEX
Powered Laser Surgical Instrument
1457
GEI
Electrosurgical, Cutting &...
1195
LLZ
System, Image Processing,...
1152
HRS
Plate, Fixation, Bone
947
LNH
System, Nuclear Magnetic...
818
IYN
System, Imaging, Pulsed Doppler,...
795
JWH
Prosthesis, Knee,...
788
ESD
Hearing Aid, Air-conduction,...
740
GCJ
Laparoscope, General & Plastic...
724
DZE
Implant, Endosseous, Root-form
699
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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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4
Ear, Nose, Throat
4