510k
Database
Specialties
Anesthesiology
202
Cardiovascular
731
Chemistry
187
Dental
459
Ear, Nose, Throat
88
Gastroenterology & Urology
389
General & Plastic Surgery
762
General Hospital
468
Hematology
77
Immunology
62
Medical Genetics
1
Microbiology
274
Neurology
294
Obstetrics & Gynecology
113
Ophthalmic
76
Orthopedic
1471
Pathology
26
Physical Medicine
151
Radiology
1079
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
165
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
123
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
104
GEI
Electrosurgical, Cutting &...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Mc3 Incorporated
Medical Device Manufacturer
·
US , Dexter , MI
Mc3 Incorporated - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2017
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Mc3 Incorporated
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 09, 2020
Nautilus Smart ECMO Module
K191935
·
BYS
Cardiovascular
·
265d
Cleared
Oct 29, 2018
MC3 Vascular Access Kit 21030
K182914
·
DRE
Cardiovascular
·
11d
Cleared
Jul 16, 2018
MC3 Jugular Dual Lumen Catheter
K180151
·
PZS
Cardiovascular
·
178d
Cleared
Nov 16, 2017
MC3 QuickFlow Dual Lumen Catheter
K171610
·
PZS
Cardiovascular
·
168d
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4
Cardiovascular
4