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4263
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3201
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2735
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463
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2285
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3843
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3545
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773
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774
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15
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1404
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1690
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849
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492
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163
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958
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4596
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System, Image Processing,...
725
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Plate, Fixation, Bone
671
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Electrosurgical, Cutting &...
535
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System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
431
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
386
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Manufacturers
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Manufacturers
US
Hologic, Inc.
Medical Device Manufacturer
·
US , Waltham , MA
Hologic, Inc. - FDA 510(k) Cleared Devices
115 submissions
·
111 cleared
·
Since 1987
Official Website
115
Total
111
Cleared
2
Denied
26
devices
26-26 of 26
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1
2
Cleared
Nov 20, 2015
ProFlu+ Assay
K153219
·
OCC
Microbiology
·
15d
1
2
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115
Radiology
62
Microbiology
26
Obstetrics & Gynecology
15
Pathology
5
General Hospital
3
Gastroenterology & Urology
3
General & Plastic Surgery
1