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1514
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5415
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4566
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3251
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540
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2868
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4725
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4192
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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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1012
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557
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8463
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355
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1072
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5540
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1365
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System, Image Processing,...
800
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698
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Electrosurgical, Cutting &...
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
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System, Nuclear Magnetic...
499
LZA
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
29
devices
26-29 of 29
Filters
1
2
Cleared
Feb 23, 2000
SYNTHETIC VDRL ANTIGEN
K993633
·
GMQ
Microbiology
·
119d
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