510k
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1022
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4327
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3210
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2778
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464
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2345
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3937
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3619
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781
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775
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15
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1404
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1755
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859
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492
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165
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959
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4605
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System, Image Processing,...
725
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689
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Electrosurgical, Cutting &...
558
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System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
464
MAX
Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
US
AtriCure, Inc.
Medical Device Manufacturer
·
US , West Chester , OH
AtriCure, Inc. - FDA 510(k) Cleared Devices
59 submissions
·
59 cleared
·
Since 2001
Official Website
59
Total
59
Cleared
0
Denied
27
devices
26-27 of 27
Filters
1
2
Cleared
Jul 12, 2006
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
K061593
·
OCL
Cardiovascular
·
34d
Cleared
Jun 13, 2005
ATRICURE ISOLATOR TRANSPOLAR PEN
K050459
·
OCL
Cardiovascular
·
110d
1
2
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59
Cardiovascular
27
General & Plastic Surgery
25
Neurology
7