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4496
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3346
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2794
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469
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2444
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4116
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3840
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808
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796
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1737
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1772
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884
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497
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963
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690
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568
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System, Imaging, Pulsed Doppler,...
535
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521
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Prosthesis, Knee,...
493
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
431
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Intervertebral Fusion Device...
406
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Mask, Surgical
400
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Manufacturers
US
Biostim, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Biostim, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1980
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biostim, Inc.
Neurology
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 01, 1985
AQUAFORM ELECTRODES WITH AQUAPORE
K844023
·
GXY
Neurology
·
109d
Cleared
Apr 18, 1984
CLINICAL CARE STIMULATOR
K840725
Neurology
·
57d
Cleared
Mar 23, 1982
SYSTEM 10
K820678
·
GZJ
Neurology
·
12d
Cleared
Sep 26, 1980
ANASTIM II TRANSCUTANEOUS ELECTRICAL
K802227
·
GZJ
Neurology
·
14d
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5
Neurology
4
Physical Medicine
1