510k
Database
Specialties
Anesthesiology
372
Cardiovascular
1177
Chemistry
287
Dental
873
Ear, Nose, Throat
161
Gastroenterology & Urology
688
General & Plastic Surgery
1477
General Hospital
868
Hematology
108
Immunology
77
Medical Genetics
1
Microbiology
385
Neurology
643
Obstetrics & Gynecology
266
Ophthalmic
171
Orthopedic
2166
Pathology
41
Physical Medicine
349
Radiology
1714
Toxicology
135
Categories
GEX
Powered Laser Surgical Instrument
250
QIH
Automated Radiological Image...
224
IYN
System, Imaging, Pulsed Doppler,...
221
LLZ
System, Image Processing,...
219
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
207
OLO
Orthopedic Stereotaxic Instrument
180
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Medien International Co, Ltd.
Medical Device Manufacturer
·
US , Echo , OR
Medien International Co, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2010
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medien International Co, Ltd.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 13, 2017
Galaxy R Digital Radiography Upgrade
K172435
·
MQB
Radiology
·
63d
Cleared
Jan 17, 2014
GALAXY PLUS
K132921
·
MQB
Radiology
·
122d
Cleared
Oct 05, 2010
DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600
K093816
·
KPR
Radiology
·
298d
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3
Radiology
3