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4515
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3346
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2794
Ear, Nose, Throat
469
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2444
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4164
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3851
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808
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796
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15
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1914
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1772
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885
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497
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167
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963
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4789
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System, Image Processing,...
730
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696
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569
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System, Imaging, Pulsed Doppler,...
535
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Powered Laser Surgical Instrument
521
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Prosthesis, Knee,...
517
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
406
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Screw, Fixation, Bone
401
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Manufacturers
US
Amplus Corp.
Medical Device Manufacturer
·
US , Boulder , CO
Amplus Corp. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1988
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Amplus Corp.
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 24, 1990
AMPLAID 770 ADMITTANCE METER
K903066
·
ETY
Ear, Nose, Throat
·
104d
Cleared
Oct 12, 1989
AMPLAID A308 CLINICAL AUDIOMETER
K891988
·
EWO
Ear, Nose, Throat
·
198d
Cleared
Feb 23, 1988
AMPLAID 309 CLINICAL AUDIOMETER
K880059
·
EWO
Ear, Nose, Throat
·
47d
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4
Ear, Nose, Throat
3
Neurology
1