510k
Database
Specialties
Anesthesiology
130
Cardiovascular
566
Chemistry
162
Dental
309
Ear, Nose, Throat
68
Gastroenterology & Urology
286
General & Plastic Surgery
512
General Hospital
369
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1287
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
MAX
Intervertebral Fusion Device...
83
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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Reports
About
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Somnomedics GmbH
Medical Device Manufacturer
·
US , Washington , DC
Somnomedics GmbH - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2007
7
Total
7
Cleared
0
Denied
FDA 510(k) cleared devices by Somnomedics GmbH
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 08, 2024
HomeSleepTest (HST, HST REM+)
K240700
·
OLV
Neurology
·
269d
Cleared
Jun 15, 2022
EEG-acp
K212325
·
GYB
Neurology
·
324d
Cleared
Aug 12, 2020
SOMNOscreen plus
K201054
·
OLV
Neurology
·
113d
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7
Anesthesiology
3
Neurology
3
Cardiovascular
1