510k
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1091
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4406
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3258
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2793
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468
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2416
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4110
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3826
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805
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782
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15
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1726
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1765
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878
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497
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7544
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166
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963
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4665
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System, Image Processing,...
729
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689
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568
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System, Imaging, Pulsed Doppler,...
533
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Powered Laser Surgical Instrument
520
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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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Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
US
Hybritech, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Hybritech, Inc. - FDA 510(k) Cleared Devices
63 submissions
·
63 cleared
·
Since 1981
63
Total
63
Cleared
0
Denied
53
devices
51-53 of 53
Filters
1
2
3
Cleared
Oct 13, 1981
TANDEM QUALITATIVE HCG KIT
K812461
·
JHI
Chemistry
·
43d
Cleared
Sep 01, 1981
TANDEM PAP KIT - (PARTS I & II)
K811959
·
JFH
Chemistry
·
54d
Cleared
May 29, 1981
TAN DEM* - IGE KIT
K802913
·
DGC
Chemistry
·
192d
1
2
3
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63
Chemistry
53
Immunology
6
Microbiology
4