510k
Database
Specialties
Anesthesiology
668
Cardiovascular
2041
Chemistry
447
Dental
1651
Ear, Nose, Throat
298
Gastroenterology & Urology
1159
General & Plastic Surgery
2549
General Hospital
2328
Hematology
142
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125
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12
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553
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1144
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521
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348
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3610
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57
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556
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2893
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165
Categories
LLZ
System, Image Processing,...
474
LZA
Polymer Patient Examination Glove
438
GEX
Powered Laser Surgical Instrument
417
FXX
Mask, Surgical
386
GEI
Electrosurgical, Cutting &...
364
IYN
System, Imaging, Pulsed Doppler,...
353
HRS
Plate, Fixation, Bone
338
QIH
Automated Radiological Image...
285
MAX
Intervertebral Fusion Device...
280
OLO
Orthopedic Stereotaxic Instrument
274
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Manufacturers
US
Sanofi
Medical Device Manufacturer
·
US , Cambridge , MA
Sanofi - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2017
Official Website
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sanofi
General Hospital
✕
1
devices
1-1 of 1
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Cleared
May 26, 2017
My Dose Coach
K171230
·
NDC
General Hospital
·
29d
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1
General Hospital
1