510k
Database
Specialties
Anesthesiology
1330
Cardiovascular
4923
Chemistry
3442
Dental
2813
Ear, Nose, Throat
475
Gastroenterology & Urology
2514
General & Plastic Surgery
4253
General Hospital
3895
Hematology
852
Immunology
801
Medical Genetics
15
Microbiology
1921
Neurology
1841
Obstetrics & Gynecology
893
Ophthalmic
498
Orthopedic
8086
Pathology
176
Physical Medicine
978
Radiology
5179
Toxicology
1258
Categories
LLZ
System, Image Processing,...
757
HRS
Plate, Fixation, Bone
696
IYN
System, Imaging, Pulsed Doppler,...
609
GEI
Electrosurgical, Cutting &...
570
GEX
Powered Laser Surgical Instrument
523
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
436
HWC
Screw, Fixation, Bone
404
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Manufacturers
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Manufacturers
US
General Electric Medical Systems Information Techn
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
Radiology
1
Anesthesiology
1
Neurology
1