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4946
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3701
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2821
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482
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2543
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4286
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3952
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889
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897
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506
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8239
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187
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978
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5194
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758
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696
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609
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Electrosurgical, Cutting &...
579
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Powered Laser Surgical Instrument
526
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
475
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Intervertebral Fusion Device...
444
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Thoracolumbosacral Pedicle Screw...
438
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Manufacturers
US
Biomedix, Inc.
Medical Device Manufacturer
·
US , Spencer , IN
Biomedix, Inc. - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 1993
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomedix, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 29, 2014
SELEC-3 I.V.ADMINISTRATION SET
K142097
·
FPA
General Hospital
·
28d
Cleared
Sep 16, 1996
BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102
K961928
·
FPA
General Hospital
·
122d
Cleared
Sep 27, 1993
SELEC-3
K925645
·
FPA
General Hospital
·
322d
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11
Cardiovascular
3
General Hospital
3
Chemistry
2
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2
Anesthesiology
1