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Anesthesiology
1358
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5125
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3959
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2897
Ear, Nose, Throat
516
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2662
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4418
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4003
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985
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1052
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15
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2099
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1930
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947
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541
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8267
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201
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978
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5355
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1325
Categories
LLZ
System, Image Processing,...
768
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Plate, Fixation, Bone
696
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System, Imaging, Pulsed Doppler,...
632
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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
Fine-Tune
Medical Device Manufacturer
·
US , Deltona , FL
Fine-Tune - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1986
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fine-Tune
Ear, Nose, Throat
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 26, 1986
MODEL CA, HEARING AID
K862095
·
ESD
Ear, Nose, Throat
·
24d
Cleared
Jun 23, 1986
MODEL PC HEARING AID
K861939
·
ESD
Ear, Nose, Throat
·
34d
Cleared
Jun 23, 1986
MODEL HP HEARING AID
K862036
·
ESD
Ear, Nose, Throat
·
25d
Cleared
Apr 23, 1986
MODEL ST HEARING AID
K861254
·
ESD
Ear, Nose, Throat
·
20d
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Ear, Nose, Throat
4