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1517
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5416
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4574
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3251
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540
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2869
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4725
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4194
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1087
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1351
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15
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2521
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2004
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1013
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557
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8470
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356
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1080
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5544
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1365
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System, Image Processing,...
800
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699
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695
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System, Imaging, Pulsed Doppler,...
633
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Powered Laser Surgical Instrument
537
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Prosthesis, Knee,...
524
LNH
System, Nuclear Magnetic...
499
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Polymer Patient Examination Glove
490
MAX
Intervertebral Fusion Device...
465
NKB
Thoracolumbosacral Pedicle Screw...
448
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Search FDA 510(k) devices
510k Database
Manufacturers
US
Centers For Disease Control and Prevention
Medical Device Manufacturer
·
US , Mchenry , IL
Centers For Disease Control and Prevention - FDA 510(k) Cleared Devic...
29 submissions
·
25 cleared
·
Since 1981
29
Total
25
Cleared
4
Denied
28
devices
26-28 of 28
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1
2
Cleared
Oct 26, 1982
SERA FOR ANTINUCLEAR ANTIBODIES
K820945
·
DHN
Microbiology
·
203d
Cleared
Sep 08, 1981
LEGIONELLA DIRECT FLUORESCENT ANTIBODY
K812006
·
LHL
Microbiology
·
54d
Cleared
Sep 08, 1981
LEGIONELLA INDIRECT FLUOR. ANTIBODY
K812007
·
LHL
Microbiology
·
54d
1
2
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29
Microbiology
28
Toxicology
1