510k
Database
Specialties
Anesthesiology
515
Cardiovascular
1595
Chemistry
356
Dental
1290
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2118
General Hospital
1918
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
934
Obstetrics & Gynecology
423
Ophthalmic
267
Orthopedic
2684
Pathology
52
Physical Medicine
508
Radiology
2302
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
393
LLZ
System, Image Processing,...
361
GEX
Powered Laser Surgical Instrument
348
FXX
Mask, Surgical
310
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
Browse all 339 categories →
Search
Reports
Glossary
About
Home
El.En S.P.A.
Medical Device Manufacturer
·
US , Hopkinton , MA
El.En S.P.A. - FDA 510(k) Cleared Devices
15 submissions
·
15 cleared
·
Since 2014
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - El.En S.P.A.
Physical Medicine
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 19, 2023
DEKA LILY
K233470
·
NGX
Physical Medicine
·
55d
Cleared
Sep 01, 2023
DEKA SIMON
K232334
·
IPF
Physical Medicine
·
28d
Filters
Filter by Specialty
All
15
General & Plastic Surgery
13
Physical Medicine
2