510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
930
General & Plastic Surgery
2136
General Hospital
1991
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2705
Pathology
52
Physical Medicine
515
Radiology
2353
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
263
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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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) Regulatory Record - 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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All
5
Ear, Nose, Throat
3
Neurology
2