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163
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1724
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GEX
Powered Laser Surgical Instrument
250
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Automated Radiological Image...
228
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222
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System, Imaging, Pulsed Doppler,...
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Plate, Fixation, Bone
216
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Electrosurgical, Cutting &...
208
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Orthopedic Stereotaxic Instrument
180
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Alltech Medical Systems America, Inc.
Medical Device Manufacturer
·
US , Solon , OH
Alltech Medical Systems America, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2008
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alltech Medical Systems America, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 10, 2017
Comfort EC710
K163192
·
LNH
Radiology
·
146d
Cleared
Feb 03, 2015
ECHOSTAR COMFORT 1.5T MRI
K141945
·
LNH
Radiology
·
201d
Cleared
May 02, 2012
ECHOSTAR SPICA 1.5T MR SYSTEM
K113511
·
LNH
Radiology
·
156d
Cleared
Aug 06, 2008
ALLTECH ECHOSTAR 1.5 T MR SYSTEM
K082100
·
LNH
Radiology
·
12d
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4
Radiology
4