510k
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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689
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568
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System, Imaging, Pulsed Doppler,...
533
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Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
464
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
CA
Scican
Medical Device Manufacturer
·
CA , Toronto, Ontario
Scican - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 1991
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scican
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 19, 2006
K-SPRAY, MODEL 085-2715
K062418
·
EFB
Dental
·
62d
Cleared
Feb 04, 1997
TCB TEMPORARY CROWN AND BRIDGE MATERIAL
K964691
·
EBG
Dental
·
74d
Cleared
Jan 11, 1995
POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)
K945142
·
ELW
Dental
·
83d
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9
General Hospital
6
Dental
3