510k
Database
Specialties
Anesthesiology
198
Cardiovascular
720
Chemistry
185
Dental
449
Ear, Nose, Throat
86
Gastroenterology & Urology
382
General & Plastic Surgery
750
General Hospital
460
Hematology
74
Immunology
61
Medical Genetics
1
Microbiology
271
Neurology
286
Obstetrics & Gynecology
111
Ophthalmic
75
Orthopedic
1464
Pathology
26
Physical Medicine
145
Radiology
1066
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
161
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
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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Serim Research Corporation
Medical Device Manufacturer
·
US , Elkhart , IN
Serim Research Corporation - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Serim Research Corporation
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 02, 2020
WAVICIDE-OPA MEC Indicator
K202565
·
JOJ
General Hospital
·
89d
Cleared
Apr 02, 2020
QwikCheck Chemical Indicators
K192445
·
JOJ
General Hospital
·
209d
Filters
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2
General Hospital
2