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1321
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4794
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3398
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2802
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474
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2464
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4193
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3876
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849
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798
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1914
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1836
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893
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497
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8079
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169
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967
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5126
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1252
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System, Image Processing,...
757
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696
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System, Imaging, Pulsed Doppler,...
579
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Electrosurgical, Cutting &...
570
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Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
475
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Intervertebral Fusion Device...
436
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Thoracolumbosacral Pedicle Screw...
403
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Manufacturers
US
Ela Medical, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Ela Medical, Inc. - FDA 510(k) Cleared Devices
43 submissions
·
36 cleared
·
Since 1979
43
Total
36
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ela Medical, Inc.
Dental
✕
1
devices
1-1 of 1
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Cleared
Aug 15, 1995
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
K952363
·
ELA
Dental
·
106d
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43
Cardiovascular
42
Dental
1