510k
Database
Specialties
Anesthesiology
208
Cardiovascular
743
Chemistry
187
Dental
473
Ear, Nose, Throat
92
Gastroenterology & Urology
398
General & Plastic Surgery
784
General Hospital
481
Hematology
77
Immunology
64
Medical Genetics
1
Microbiology
278
Neurology
310
Obstetrics & Gynecology
121
Ophthalmic
81
Orthopedic
1484
Pathology
26
Physical Medicine
155
Radiology
1105
Toxicology
95
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
114
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
98
MBI
Fastener, Fixation,...
93
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Intromedic Co., Ltd.
Medical Device Manufacturer
·
KR , Guro-Gu , Seoul
Intromedic Co., Ltd. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2011
10
Total
10
Cleared
0
Denied
FDA 510(k) cleared devices by Intromedic Co., Ltd.
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 21, 2013
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
K131131
·
EOX
Ear, Nose, Throat
·
60d
Cleared
Jun 20, 2012
E.G. SCAN II ESPHAGOSCOPE SYSTEM
K120702
·
EOX
Ear, Nose, Throat
·
104d
Cleared
Oct 21, 2011
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
K111030
·
EOX
Ear, Nose, Throat
·
191d
Filters
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10
Gastroenterology & Urology
7
Ear, Nose, Throat
3