510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1685
Chemistry
370
Dental
1345
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2202
General Hospital
2052
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
472
Neurology
975
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2970
Pathology
52
Physical Medicine
515
Radiology
2458
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
222
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Dong-A Pharmaceutical Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Dong-A Pharmaceutical Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dong-A Pharmaceutical Co., Ltd.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 21, 2022
Tempo Tampon
K212277
·
HEB
Obstetrics & Gynecology
·
275d
Cleared
Sep 17, 2021
Tempo Natural Tampon
K212272
·
HEB
Obstetrics & Gynecology
·
59d
Filters
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2
Obstetrics & Gynecology
2