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4590
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11424
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10042
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7210
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2255
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5975
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9845
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8140
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2242
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2840
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18
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5372
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3415
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2166
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1759
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13764
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766
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1886
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9323
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2368
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GEX
Powered Laser Surgical Instrument
1681
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Electrosurgical, Cutting &...
1319
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System, Image Processing,...
1236
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Plate, Fixation, Bone
1043
IYN
System, Imaging, Pulsed Doppler,...
922
ESD
Hearing Aid, Air-conduction,...
879
LNH
System, Nuclear Magnetic...
872
JWH
Prosthesis, Knee,...
840
GCJ
Laparoscope, General & Plastic...
839
DZE
Implant, Endosseous, Root-form
821
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Manufacturers
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510k Database
Manufacturers
FR
Alseal
Medical Device Manufacturer
·
FR , Besancon
Alseal - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alseal
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 25, 2016
HQS Introducer (Model 2064-HQS)
K153494
·
DYB
Cardiovascular
·
265d
Cleared
Feb 14, 2014
XCATH
K133296
·
DYB
Cardiovascular
·
112d
Cleared
Jul 31, 2012
HQS INTRODUCER
K113849
·
DYB
Cardiovascular
·
215d
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3
Cardiovascular
3