Bien-Air Surgery SA
Medical device manufacturer in Le Noirmont, CH.
5510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K221184 | ORiGO SystemERL · Traditional | 11/02/2022SE |
| K213697 | ORiGO SystemHBC · Traditional | 10/31/2022SE |
| K173066 | OSSEODUO Shaver and Drill SystemHBC · Traditional | 06/22/2018SE |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot…ERL · Traditional | 03/04/2015SE |
| K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80KERL · Traditional | 03/20/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0180-2021 Class II | Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The…The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | 09/11/2020Open, Classified |
| Z-0179-2021 Class II | Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The…The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | 09/11/2020Open, Classified |
| Z-0178-2021 Class II | Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an…The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | 09/11/2020Open, Classified |
| Z-0177-2021 Class II | Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product…The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | 09/11/2020Open, Classified |
| Z-0176-2021 Class II | Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to…The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | 09/11/2020Open, Classified |