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1355
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5032
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3958
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2897
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501
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2656
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4362
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3998
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984
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936
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15
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1966
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1926
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945
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511
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8261
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189
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978
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5352
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1325
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768
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696
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631
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Electrosurgical, Cutting &...
595
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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
MAX
Intervertebral Fusion Device...
444
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Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Alexotek Co.
Medical Device Manufacturer
·
US , Mchenry , IL
Alexotek Co. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1984
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alexotek Co.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 01, 1988
MINILINE BRACKET
K881789
·
EJF
Dental
·
36d
Cleared
Apr 05, 1984
ALEXOTEK LINGUAL TUBES
K834446
·
DZD
Dental
·
111d
Cleared
Feb 28, 1984
LABIAL CUSPID TUBE
K834392
·
DZD
Dental
·
76d
Cleared
Feb 03, 1984
ALEXOLOK BRACKET
K834272
·
EJF
Dental
·
57d
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4
Dental
4