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 Ear, Nose, Throat ✕
3 devices
1-3 of 3
Cleared Nov 02, 2022
ORiGO System
K221184 · ERL
Ear, Nose, Throat · 191d
Cleared Mar 04, 2015
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control...
K143492 · ERL
Ear, Nose, Throat · 86d
Cleared Mar 20, 2009
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
K083720 · ERL
Ear, Nose, Throat · 95d
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