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Bien-Air Surgery Sa

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
5
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0179-2021Class IIStryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini September 11, 2020
Z-0177-2021Class IIBien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product UsSeptember 11, 2020
Z-0178-2021Class IIBien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medicalSeptember 11, 2020
Z-0180-2021Class IIEntellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus MedicSeptember 11, 2020
Z-0176-2021Class IIBien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert elecSeptember 11, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K221184ORiGO SystemNovember 2, 2022
K213697ORiGO SystemOctober 31, 2022
K173066OSSEODUO Shaver and Drill SystemJune 22, 2018
K143492OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOMarch 4, 2015
K083720OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80KMarch 20, 2009