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
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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Steris
Medical Device Manufacturer
·
US , Mentor , OH
Steris - FDA 510(k) Cleared Devices
20 submissions
·
19 cleared
·
Since 2021
20
Total
19
Cleared
1
Denied
FDA 510(k) cleared devices by Steris
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 08, 2024
Articulator Injection Needle (00711807), Articulator Injection Needle...
K232826
·
FBK
Gastroenterology & Urology
·
177d
Cleared
Oct 20, 2023
BioShield Biopsy Valve (00711124)
K232951
·
ODC
Gastroenterology & Urology
·
29d
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20
General Hospital
16
General & Plastic Surgery
2
Gastroenterology & Urology
2