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6307
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14619
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11237
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9784
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2793
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7653
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13750
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11813
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2633
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3134
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20
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5943
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4777
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3198
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2937
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16562
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881
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3010
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12533
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2637
Categories
GEX
Powered Laser Surgical Instrument
2371
LLZ
System, Image Processing,...
1994
GEI
Electrosurgical, Cutting &...
1870
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Implant, Endosseous, Root-form
1286
HRS
Plate, Fixation, Bone
1259
IYN
System, Imaging, Pulsed Doppler,...
1113
GCJ
Laparoscope, General & Plastic...
1099
LZA
Polymer Patient Examination Glove
1050
LNH
System, Nuclear Magnetic...
983
HWC
Screw, Fixation, Bone
973
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Search FDA 510(k) devices
510k Database
Manufacturers
US
General Electric Medical Systems Information Techn
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Medical Device Manufacturer
·
US , Sugarland , TX
General Electric Medical Systems Information Techn - FDA 510(k) Clear...
33 submissions
·
33 cleared
·
Since 1999
33
Total
33
Cleared
0
Denied
28
devices
26-28 of 28
Filters
1
2
Cleared
Oct 20, 1999
CASE 8000 EXERCISE TESTING SYSTEM
K991014
·
LOS
Cardiovascular
·
208d
Cleared
Aug 19, 1999
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC...
K991735
·
LOS
Cardiovascular
·
90d
Cleared
Jul 14, 1999
SOLAR 9500 INFORMATION MONITOR
K990068
·
MHX
Cardiovascular
·
187d
1
2
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33
Cardiovascular
28
Obstetrics & Gynecology
2
Neurology
1
Radiology
1
Anesthesiology
1