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3443
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9751
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8476
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5893
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1949
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5112
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8049
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6578
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1964
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2501
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16
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4740
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2849
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1842
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1436
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12302
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622
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1556
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8191
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2128
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GEX
Powered Laser Surgical Instrument
1289
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Electrosurgical, Cutting &...
1165
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System, Image Processing,...
1128
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Plate, Fixation, Bone
923
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System, Nuclear Magnetic...
818
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System, Imaging, Pulsed Doppler,...
793
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Prosthesis, Knee,...
787
ESD
Hearing Aid, Air-conduction,...
740
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Laparoscope, General & Plastic...
702
DZE
Implant, Endosseous, Root-form
673
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Manufacturers
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Search FDA 510(k) devices
510k Database
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
Filters
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