510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
Dental
1334
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
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466
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963
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433
Ophthalmic
274
Orthopedic
2875
Pathology
52
Physical Medicine
515
Radiology
2430
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Oneday Biotech Co., Ltd.
Medical Device Manufacturer
·
KR , Daegu
Oneday Biotech Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Oneday Biotech Co., Ltd.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 21, 2024
Oneday Implant Abutment
K231753
·
NHA
Dental
·
251d
Cleared
Aug 23, 2023
Oneday Mini Implant System
K222946
·
DZE
Dental
·
330d
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Dental
2