510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1699
Chemistry
374
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2213
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2062
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126
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100
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8
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474
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980
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438
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282
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2988
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52
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515
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2468
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155
Categories
LZA
Polymer Patient Examination Glove
414
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Amt Engineering Co., Ltd.
Medical Device Manufacturer
·
KR , Gyeonggi Do
Amt Engineering Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Amt Engineering Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 06, 2024
COPRO 3
K241672
·
GEX
General & Plastic Surgery
·
87d
Cleared
May 04, 2023
Lucas Plus
K230340
·
GEX
General & Plastic Surgery
·
86d
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General & Plastic Surgery
2