510k
Database
Specialties
Anesthesiology
521
Cardiovascular
1607
Chemistry
356
Dental
1299
Ear, Nose, Throat
234
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1972
Hematology
126
Immunology
91
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8
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449
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939
Obstetrics & Gynecology
425
Ophthalmic
271
Orthopedic
2695
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
402
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
345
GEI
Electrosurgical, Cutting &...
294
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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MEZOO Co., Ltd.
Medical Device Manufacturer
·
KR , Wonju-Si
MEZOO Co., Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2024
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - MEZOO Co., Ltd.
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 20, 2024
HiCardi+ H100
K232670
·
DSH
Cardiovascular
·
385d
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Cardiovascular
1