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
NHA
Abutment, Implant, Dental,...
84
MBI
Fastener, Fixation,...
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.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 06, 2025
Empatica Health Monitoring Platform
K242737
·
MWI
Cardiovascular
·
268d
Cleared
Oct 30, 2023
Empatica Health Monitoring Platform
K230457
·
MWI
Cardiovascular
·
251d
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8
Neurology
5
Cardiovascular
2
Anesthesiology
1