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3210
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2788
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465
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2369
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3973
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3708
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788
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776
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15
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1404
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1755
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864
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492
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165
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962
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725
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689
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560
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533
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519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
464
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Intervertebral Fusion Device...
403
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400
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Screw, Fixation, Bone
392
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Manufacturers
US
Armkel, LLC
Medical Device Manufacturer
·
US , Mchenry , IL
Armkel, LLC - FDA 510(k) Cleared Devices
68 submissions
·
68 cleared
·
Since 1979
68
Total
68
Cleared
0
Denied
29
devices
26-29 of 29
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1
2
Cleared
Nov 24, 1980
ANSWER AT-HOME PREGNANCY TEST KIT
K802660
·
JHJ
Chemistry
·
31d
Cleared
Oct 23, 1980
UCG-BETA STAT
K802421
·
JHJ
Chemistry
·
17d
Cleared
Oct 23, 1980
UCG-BETA SLIDE
K802435
·
JHJ
Chemistry
·
17d
Cleared
May 03, 1979
HEATING BLOCK, WAMPOLE 37 C
K790549
·
JRG
Chemistry
·
44d
1
2
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68
Chemistry
29
Microbiology
22
Obstetrics & Gynecology
9
Immunology
7
Dental
1