510k
Database
Specialties
Anesthesiology
475
Cardiovascular
1438
Chemistry
336
Dental
1131
Ear, Nose, Throat
210
Gastroenterology & Urology
840
General & Plastic Surgery
1891
General Hospital
1436
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
426
Neurology
811
Obstetrics & Gynecology
362
Ophthalmic
237
Orthopedic
2473
Pathology
49
Physical Medicine
439
Radiology
2060
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
305
LZA
Polymer Patient Examination Glove
277
GEI
Electrosurgical, Cutting &...
260
QIH
Automated Radiological Image...
256
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
204
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
Browse all 339 categories →
Search
Reports
Glossary
About
Home
Ote-Biomedica Elettronica S.P.A
Medical Device Manufacturer
·
US , Cambridge , MA
Ote-Biomedica Elettronica S.P.A - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1988
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ote-Biomedica Elettronica S.P.A
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 18, 1988
SIM 4000C
K874548
·
IYO
Radiology
·
167d
Cleared
Apr 07, 1988
SIM 4000I
K873845
·
IYO
Radiology
·
198d
Filters
Filter by Specialty
All
2
Radiology
2