510k
Database
Specialties
Anesthesiology
201
Cardiovascular
729
Chemistry
187
Dental
458
Ear, Nose, Throat
86
Gastroenterology & Urology
387
General & Plastic Surgery
757
General Hospital
466
Hematology
77
Immunology
62
Medical Genetics
1
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273
Neurology
292
Obstetrics & Gynecology
113
Ophthalmic
76
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1467
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26
Physical Medicine
150
Radiology
1078
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
164
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Synedgen, Inc.
Medical Device Manufacturer
·
US , Claremont , CA
Synedgen, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Synedgen, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
May 27, 2020
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
K193336
·
OLR
General & Plastic Surgery
·
177d
Cleared
Feb 21, 2018
Catasyn Advanced Technology Wound Hydrogel
K172338
·
FRO
General & Plastic Surgery
·
203d
Cleared
Aug 21, 2015
SynePure Wound Cleanser
K143444
·
FRO
General & Plastic Surgery
·
262d
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3
General & Plastic Surgery
3