510k
Database
Specialties
Anesthesiology
133
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
371
Hematology
67
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56
Medical Genetics
0
Microbiology
232
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163
Obstetrics & Gynecology
61
Ophthalmic
49
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1291
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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S4 Medical Corp.
Medical Device Manufacturer
·
US , Chagrin Falls , OH
S4 Medical Corp. - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 2023
2
Total
1
Cleared
1
Denied
FDA 510(k) cleared devices by S4 Medical Corp.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 09, 2024
esolution® Esophageal Retractor
K243233
·
QXU
Cardiovascular
·
31d
Not Cleared
Sep 06, 2023
esolution
DEN230006
·
QXU
Cardiovascular
·
225d
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Cardiovascular
2