510k
Database
Specialties
Anesthesiology
132
Cardiovascular
568
Chemistry
162
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
370
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1288
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Empatica S.R.L.
Medical Device Manufacturer
·
IT , Milano
Empatica S.R.L. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2018
8
Total
8
Cleared
0
Denied
FDA 510(k) cleared devices by Empatica S.R.L.
Neurology
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 22, 2025
EmbraceMini
K252981
·
LEL
Neurology
·
96d
Cleared
Jun 19, 2025
EpiMonitor
K250515
·
POS
Neurology
·
118d
Cleared
Feb 15, 2024
EpiMonitor
K232915
·
POS
Neurology
·
149d
Cleared
Dec 20, 2018
Embrace
K181861
·
POS
Neurology
·
161d
Cleared
Jan 26, 2018
Embrace
K172935
·
POS
Neurology
·
122d
Filters
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8
Neurology
5
Cardiovascular
2
Anesthesiology
1