510k
Database
Specialties
Anesthesiology
487
Cardiovascular
1478
Chemistry
342
Dental
1165
Ear, Nose, Throat
216
Gastroenterology & Urology
856
General & Plastic Surgery
1936
General Hospital
1477
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
839
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2550
Pathology
49
Physical Medicine
454
Radiology
2105
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
269
QIH
Automated Radiological Image...
260
IYN
System, Imaging, Pulsed Doppler,...
253
HRS
Plate, Fixation, Bone
250
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
177
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Sodemsystems
Medical Device Manufacturer
·
US , North Attleboro , MA
Sodemsystems - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1994
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sodemsystems
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 28, 2003
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K023070
·
ERL
Ear, Nose, Throat
·
134d
Cleared
Sep 21, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
K012456
·
ERL
Ear, Nose, Throat
·
51d
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8
Neurology
5
Ear, Nose, Throat
2
Orthopedic
1