510k
Database
Specialties
Anesthesiology
198
Cardiovascular
722
Chemistry
186
Dental
450
Ear, Nose, Throat
86
Gastroenterology & Urology
383
General & Plastic Surgery
751
General Hospital
462
Hematology
75
Immunology
61
Medical Genetics
1
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272
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289
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112
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75
Orthopedic
1464
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26
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146
Radiology
1069
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
162
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...
107
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Enzysurge , Ltd.
Medical Device Manufacturer
·
US , Somerset , MA
Enzysurge , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2006
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Enzysurge , Ltd.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 08, 2020
SilverStream Gel
K200767
·
FRO
General & Plastic Surgery
·
197d
Cleared
Dec 10, 2009
SILVERSTREAM AND DERMASEPT
K093227
·
FRO
General & Plastic Surgery
·
57d
Cleared
Feb 27, 2006
DERMASTREAM
K060046
·
NAD
General & Plastic Surgery
·
52d
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3
General & Plastic Surgery
3