510k
Database
Specialties
Anesthesiology
488
Cardiovascular
1482
Chemistry
342
Dental
1166
Ear, Nose, Throat
216
Gastroenterology & Urology
857
General & Plastic Surgery
1936
General Hospital
1477
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
433
Neurology
842
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2552
Pathology
49
Physical Medicine
455
Radiology
2111
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
310
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
269
QIH
Automated Radiological Image...
261
IYN
System, Imaging, Pulsed Doppler,...
253
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
177
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Siemens Elema AB
Medical Device Manufacturer
·
US , Mchenry , IL
Siemens Elema AB - FDA 510(k) Cleared Devices
63 submissions
·
60 cleared
·
Since 1978
63
Total
60
Cleared
0
Denied
26
devices
26-26 of 26
Filters
1
2
Cleared
May 02, 1980
PULSE GENERATORS MODELS 657 & 677
K800387
·
DXY
Cardiovascular
·
70d
1
2
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63
Anesthesiology
34
Cardiovascular
26
General Hospital
1
Radiology
1
Toxicology
1