510k
Database
Specialties
Anesthesiology
411
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1243
Chemistry
309
Dental
940
Ear, Nose, Throat
180
Gastroenterology & Urology
729
General & Plastic Surgery
1593
General Hospital
988
Hematology
113
Immunology
80
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6
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401
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694
Obstetrics & Gynecology
299
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185
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2247
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43
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371
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1813
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138
Categories
GEX
Powered Laser Surgical Instrument
261
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
236
IYN
System, Imaging, Pulsed Doppler,...
224
GEI
Electrosurgical, Cutting &...
222
HRS
Plate, Fixation, Bone
220
OLO
Orthopedic Stereotaxic Instrument
184
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
153
MAX
Intervertebral Fusion Device...
149
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Nox Medical Ehf
Medical Device Manufacturer
·
IS , Reykjavik
Nox Medical Ehf - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2015
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nox Medical Ehf
Neurology
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 20, 2026
Noxturnal Web
K260585
·
OLV
Neurology
·
28d
Cleared
Nov 17, 2025
DeepRESP
K252330
·
OLZ
Neurology
·
115d
Cleared
Mar 14, 2025
DeepRESP
K241960
·
OLZ
Neurology
·
254d
Cleared
Dec 23, 2024
Noxturnal Web
K241288
·
OLV
Neurology
·
230d
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5
Neurology
4
Anesthesiology
1