510k
Database
Specialties
Anesthesiology
136
Cardiovascular
570
Chemistry
165
Dental
319
Ear, Nose, Throat
68
Gastroenterology & Urology
290
General & Plastic Surgery
526
General Hospital
377
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
62
Ophthalmic
51
Orthopedic
1296
Pathology
18
Physical Medicine
88
Radiology
875
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
151
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Digimed Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Digimed Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2018
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Digimed Co., Ltd.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 03, 2023
DHX-70H, XTG-70H
K221587
·
EHD
Radiology
·
275d
Cleared
Sep 01, 2022
Hybrid C70
K220579
·
EHD
Radiology
·
192d
Cleared
Apr 22, 2022
HYBRID S70
K220574
·
EHD
Radiology
·
53d
Cleared
Aug 10, 2018
Portable X-ray System (Model: MiniX-V, Mini X-S)
K181891
·
EHD
Radiology
·
28d
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4
Radiology
4