Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Bien-Air Surgery with 5 510(k) clearances and 5 device recalls. The most recent is a 510(k) clearance dated Nov 2, 2022: ORiGO System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 2, 2022 | ORiGO SystemK221184 · ERL | 510(k) clearances |
| Oct 31, 2022 | ORiGO SystemK213697 · HBC | 510(k) clearances |
| Sep 11, 2020 | Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical enerClass II · The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Device recalls |
| Sep 11, 2020 | Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy iClass II · The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Device recalls |
| Sep 11, 2020 | Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handClass II · The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Device recalls |
| Sep 11, 2020 | Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for sClass II · The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Device recalls |
| Sep 11, 2020 | Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the lClass II · The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Device recalls |
| Jun 22, 2018 | OSSEODUO Shaver and Drill SystemK173066 · HBC | 510(k) clearances |
| Mar 4, 2015 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpieceK143492 · ERL | 510(k) clearances |
| Mar 20, 2009 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80KK083720 · ERL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
