510k
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409
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1233
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308
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929
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179
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726
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1584
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976
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113
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79
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4
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400
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689
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296
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183
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2238
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43
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370
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1810
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138
Categories
GEX
Powered Laser Surgical Instrument
260
LLZ
System, Image Processing,...
255
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Automated Radiological Image...
236
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System, Imaging, Pulsed Doppler,...
224
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Electrosurgical, Cutting &...
221
HRS
Plate, Fixation, Bone
219
OLO
Orthopedic Stereotaxic Instrument
183
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Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
148
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Computerized Medical Systems, Inc.
Medical Device Manufacturer
·
US , St. Louis , MO
Computerized Medical Systems, Inc. - FDA 510(k) Cleared Devices
23 submissions
·
23 cleared
·
Since 1985
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Computerized Medical Systems, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 06, 1987
LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.
K863535
·
DPS
Cardiovascular
·
117d
Cleared
Nov 21, 1986
LIFE-WATCH MONITOR LT-8
K863534
·
DRT
Cardiovascular
·
71d
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23
Radiology
21
Cardiovascular
2