510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1294
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Epien Medical, Inc.
Medical Device Manufacturer
·
US , Washington , DC
Epien Medical, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2013
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Epien Medical, Inc.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 09, 2021
EPIEN Dental Cleanser
K201785
·
KJJ
Dental
·
436d
Cleared
Feb 01, 2013
EPIEN ROOT CANAL CLEANSER
K123538
·
KJJ
Dental
·
77d
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Dental
2