510k
Database
Specialties
Anesthesiology
505
Cardiovascular
1565
Chemistry
354
Dental
1243
Ear, Nose, Throat
229
Gastroenterology & Urology
909
General & Plastic Surgery
2080
General Hospital
1708
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
444
Neurology
907
Obstetrics & Gynecology
413
Ophthalmic
265
Orthopedic
2660
Pathology
49
Physical Medicine
497
Radiology
2260
Toxicology
154
Categories
GEX
Powered Laser Surgical Instrument
344
LZA
Polymer Patient Examination Glove
343
LLZ
System, Image Processing,...
343
GEI
Electrosurgical, Cutting &...
289
QIH
Automated Radiological Image...
270
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
259
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
FXX
Mask, Surgical
200
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GE Healthcare Finland Oy
Medical Device Manufacturer
·
US , Madison , WI
GE Healthcare Finland Oy - FDA 510(k) Cleared Devices
30 submissions
·
30 cleared
·
Since 2007
30
Total
30
Cleared
0
Denied
FDA 510(k) Regulatory Record - GE Healthcare Finland Oy
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 22, 2020
E-EEGX, N-EEGX
K191322
·
OLT
Neurology
·
252d
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30
Anesthesiology
15
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14
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1