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563
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2008
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358
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166
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4415
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68
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System, Image Processing,...
620
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496
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481
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454
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System, Imaging, Pulsed Doppler,...
437
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397
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389
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Intervertebral Fusion Device...
379
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Thoracolumbosacral Pedicle Screw...
329
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Orthopedic Stereotaxic Instrument
317
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Manufacturers
US
American Bio Medica Corp.
Medical Device Manufacturer
·
US , Washington , DC
American Bio Medica Corp. - FDA 510(k) Cleared Devices
30 submissions
·
30 cleared
·
Since 1997
30
Total
30
Cleared
0
Denied
28
devices
26-28 of 28
Filters
1
2
Cleared
Aug 27, 1998
'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME
K981705
·
DKZ
Toxicology
·
105d
Cleared
Mar 20, 1998
RAPID DRUG SCREEN' 8 PANEL
K980872
·
DIO
Toxicology
·
14d
Cleared
Apr 14, 1997
RAPID DRUG SCREEN
K964900
·
DIO
Toxicology
·
138d
1
2
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30
Toxicology
28
Chemistry
2