510k
Database
Specialties
Anesthesiology
144
Cardiovascular
584
Chemistry
167
Dental
328
Ear, Nose, Throat
68
Gastroenterology & Urology
297
General & Plastic Surgery
543
General Hospital
387
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
236
Neurology
176
Obstetrics & Gynecology
70
Ophthalmic
53
Orthopedic
1308
Pathology
19
Physical Medicine
91
Radiology
891
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
138
OLO
Orthopedic Stereotaxic Instrument
118
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
84
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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GN Hearing A/S
Medical Device Manufacturer
·
DK , Ballerup
GN Hearing A/S - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2018
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by GN Hearing A/S
Ear, Nose, Throat
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 19, 2022
Jabra Enhance Plus
K213424
·
QDD
Ear, Nose, Throat
·
90d
Cleared
Feb 20, 2020
Tinnitus Sound Generator Module
K193303
·
KLW
Ear, Nose, Throat
·
83d
Cleared
Nov 30, 2018
Tinnitus Sound Generator Module
K180495
·
KLW
Ear, Nose, Throat
·
277d
Cleared
Jul 13, 2018
Tinnitus Sound Generator Module
K181586
·
KLW
Ear, Nose, Throat
·
28d
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Ear, Nose, Throat
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