510k
Database
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Anesthesiology
6718
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15426
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11482
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10396
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2880
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8131
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14591
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12868
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2715
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3213
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20
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6037
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5141
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3486
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3202
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17081
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900
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3322
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13291
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2720
Categories
Powered Laser Surgical Instrument
GEX
2537
System, Image Processing, Radiological
LLZ
2135
Electrosurgical, Cutting &...
GEI
2005
Implant, Endosseous, Root-form
DZE
1374
Plate, Fixation, Bone
HRS
1304
Laparoscope, General & Plastic Surgery
GCJ
1167
System, Imaging, Pulsed Doppler,...
IYN
1156
Polymer Patient Examination Glove
LZA
1153
System, Nuclear Magnetic Resonance...
LNH
1021
Screw, Fixation, Bone
HWC
1017
Browse all 339 categories →
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510k Database
Manufacturers
US
Centers For Disease Control and Prevention
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Medical Device Manufacturer
·
US , Mchenry , IL
Centers For Disease Control and Prevention - FDA 510(k) Cleared Devic...
30 submissions
·
26 cleared
·
Since 1981
30
Total
26
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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30
Microbiology
29
Toxicology
1