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
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133
Obstetrics & Gynecology
43
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41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
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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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Enbio Group AG
Medical Device Manufacturer
·
CH , Oensingen
Enbio Group AG - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Enbio Group AG
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 26, 2026
Enbio PRO
K260254
·
FLE
General Hospital
·
30d
Cleared
Feb 22, 2022
Enbio S
K213991
·
FLE
General Hospital
·
63d
Cleared
Oct 29, 2021
Enbio S
K210279
·
FLE
General Hospital
·
270d
Filters
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3
General Hospital
3