510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
164
Dental
315
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1294
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
85
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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Bien-Air Surgery SA
Medical Device Manufacturer
·
CH , Le Noirmont
Bien-Air Surgery SA - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2009
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Bien-Air Surgery SA
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 31, 2022
ORiGO System
K213697
·
HBC
Neurology
·
342d
Cleared
Jun 22, 2018
OSSEODUO Shaver and Drill System
K173066
·
HBC
Neurology
·
266d
Filters
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5
Ear, Nose, Throat
3
Neurology
2