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Database
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1037
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4339
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3222
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2789
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465
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2373
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4091
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3725
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789
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776
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15
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1492
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1755
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876
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495
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7543
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165
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963
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4605
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1238
Categories
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System, Image Processing,...
725
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Plate, Fixation, Bone
689
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Electrosurgical, Cutting &...
568
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System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
464
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
US
Sigma
Medical Device Manufacturer
·
US , MD
Sigma - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1983
Official Website
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sigma
General Hospital
✕
3
devices
1-3 of 3
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Cleared
Aug 31, 1993
SIGMA 7000 AND SIGMA70002
K926191
·
FRN
General Hospital
·
265d
Cleared
Jan 26, 1983
SIGMA 7000
K820038
·
FRN
General Hospital
·
19d
Cleared
Jan 26, 1983
SIGMA 7000-6000 INFUSION PUMPS
K830038
·
FRN
General Hospital
·
8d
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6
General Hospital
3
Hematology
2
Physical Medicine
1