510k
Database
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Anesthesiology
430
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1305
Chemistry
327
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1004
Ear, Nose, Throat
190
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779
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1695
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1096
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117
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83
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7
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412
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731
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318
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198
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2361
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44
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393
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1893
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140
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
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Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
239
IYN
System, Imaging, Pulsed Doppler,...
231
HRS
Plate, Fixation, Bone
231
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
MAX
Intervertebral Fusion Device...
161
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Ge Lunar Corp.
Medical Device Manufacturer
·
US , Madison , WI
Ge Lunar Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2001
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ge Lunar Corp.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 25, 2003
DPX SERIES BRAVO DUO BONE DENSITOMETER
K030962
·
KGI
Radiology
·
120d
Cleared
Dec 20, 2002
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
K023554
·
KGI
Radiology
·
58d
Cleared
Aug 03, 2001
ADVANCED HIP ASSESSMENT SOFTWARE
K011917
·
KGI
Radiology
·
44d
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3
Radiology
3