510k
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4313
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3201
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2736
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464
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2288
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3896
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3553
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778
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774
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15
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1404
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1737
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851
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492
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7470
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163
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958
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4597
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1235
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System, Image Processing,...
725
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689
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551
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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,...
450
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Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
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Screw, Fixation, Bone
390
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Manufacturers
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Manufacturers
US
Genzyme Corp.
Medical Device Manufacturer
·
US , Cambridge , MA
Genzyme Corp. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 1991
Official Website
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Jul 01, 1991
AMYLASE REAGENT
K912519
·
JFJ
Chemistry
·
25d
Cleared
May 22, 1991
HDL CHOLESTEROL REAGENT
K911406
·
LBR
Chemistry
·
54d
1
2
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27
Chemistry
17
Hematology
3
General & Plastic Surgery
3
Microbiology
3
Ear, Nose, Throat
1