510k
Database
Specialties
Anesthesiology
133
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
371
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1291
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Nu Eyne Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Nu Eyne Co., Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2019
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Nu Eyne Co., Ltd.
Neurology
✕
5
devices
1-5 of 5
Filters
Cleared
Jan 16, 2025
ADDNOX (BPSPM1)
K243289
·
QGL
Neurology
·
90d
Cleared
Nov 06, 2024
ELEXIR 2.0 (ALLIVE3)
K242719
·
PCC
Neurology
·
57d
Cleared
Feb 12, 2023
SMILE
K213629
·
QGL
Neurology
·
452d
Cleared
Jul 30, 2021
Elexir
K211380
·
PCC
Neurology
·
87d
Cleared
Dec 06, 2019
ALLIVE
K192773
·
PCC
Neurology
·
67d
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Neurology
5