510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
NKB
Thoracolumbosacral Pedicle Screw...
77
MBI
Fastener, Fixation,...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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About
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SurGenTec, LLC
Medical Device Manufacturer
·
US , Boca Raton , FL
SurGenTec, LLC - FDA 510(k) Cleared Devices
23 submissions
·
23 cleared
·
Since 2017
23
Total
23
Cleared
0
Denied
FDA 510(k) cleared devices by SurGenTec, LLC
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Jul 16, 2019
ALARA Neuro Access Kit
K190163
·
PDQ
Neurology
·
166d
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23
Orthopedic
18
General Hospital
2
General & Plastic Surgery
2
Neurology
1