510k
Database
Specialties
Anesthesiology
136
Cardiovascular
572
Chemistry
165
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
291
General & Plastic Surgery
528
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
62
Ophthalmic
51
Orthopedic
1297
Pathology
18
Physical Medicine
88
Radiology
877
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Ami, Inc.
Medical Device Manufacturer
·
KR , Seoul
Ami, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Ami, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 12, 2024
Picosecond Nd:YAG Laser System
K233007
·
GEX
General & Plastic Surgery
·
264d
Cleared
Jul 05, 2018
Fractional CO2 Surgical Laser System
K173359
·
GEX
General & Plastic Surgery
·
252d
Cleared
Dec 07, 2017
Q-Switched Nd:YAG Laser System
K172908
·
GEX
General & Plastic Surgery
·
73d
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3
General & Plastic Surgery
3