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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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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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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
Hematology
✕
2
devices
1-2 of 2
Filters
Cleared
May 15, 1985
MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &
K851737
·
KIT
Hematology
·
20d
Cleared
May 15, 1985
MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &
K851738
·
KIT
Hematology
·
20d
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6
General Hospital
3
Hematology
2
Physical Medicine
1