510k
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Specialties
Anesthesiology
198
Cardiovascular
720
Chemistry
185
Dental
448
Ear, Nose, Throat
86
Gastroenterology & Urology
382
General & Plastic Surgery
749
General Hospital
460
Hematology
74
Immunology
61
Medical Genetics
1
Microbiology
271
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286
Obstetrics & Gynecology
111
Ophthalmic
75
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1463
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26
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145
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1066
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
161
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
GEX
Powered Laser Surgical Instrument
122
LLZ
System, Image Processing,...
122
QIH
Automated Radiological Image...
106
GEI
Electrosurgical, Cutting &...
103
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
Medical Device Manufacturer
·
SI , Ljubljana
Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. - FDA 510(k) ...
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Mesi D.O.O.; Mesi, Development of...
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 11, 2020
Automated ankle brachial pressure index measuring device, MESI mTABLET system
K201046
·
JOM
Cardiovascular
·
234d
Cleared
Jan 11, 2018
Automated ankle brachial pressure index measuring device
K172655
·
JOM
Cardiovascular
·
128d
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2
Cardiovascular
2