Bien Air Surgery S A

FDA Filings

This page includes the latest FDA filings for Bien Air Surgery S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003800209
FEI Number3003800209
NameBIEN-AIR SURGERY SA
Owner & OperatorBien-Air Surgery SA
Contact Addressrue de l'Ouest 2b
Le Noirmont CH-JU Jura 2340 CH
Official Correspondent
  • Arnaud BILLOT
  • 041-32-9533535-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Addressrue de l Ouest 2b
Le Noirmont Jura, 2340 CH
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø3.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø2.5 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø2.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-150 80K diam EC Ø8.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-150 80K diam Ø8.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-95 80K MstickD Ø4.0St 2026-02-24
Bien-Air Surgery SA
Bur PM2-125 80K Mstick Ø4.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-95 80K Mstick Ø4.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K Mstick Ø4.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-125 80K steel Ø8.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-150 80K diam EC Ø7.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-150 80K diam Ø7.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø5.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø5.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø4.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø4.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-95 80K diam EC Ø4.5 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø3.5x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø3.5 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø3.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø3.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø2.5x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø2.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø2.5 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø2.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø1.5x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø1.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø0.5x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø3.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø3.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø2.5x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø2.5 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø3.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø5.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø4.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø2.5 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø3x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø2.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø2.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø3.5x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø3.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø2.5x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø2.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø2.5x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø2.0 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø5.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø1.5x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø1.5 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø2.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø4.0x80 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø1.5 St 2026-02-24
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø1.5 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø2.5 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø1.5x80 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-70 80K FC Ø2.5 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-70 80K diamC Ø1.0x80 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø3.5x80 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø3.0x80 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø2.5x80 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-125 80K steel Ø1.5 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø1.5x80 St 2026-02-23
Bien-Air Surgery SA
Bur PM2-95 80K Diamond coarse Ø2.0 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-95 80K Diamond coarse Ø1.0 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K Diamond coarse Ø3.0 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K Diamond coarse Ø2.0 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K Diamond coarse Ø4.5 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K Diamond coarse Ø3.5 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K Diamond coarse Ø6.0 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K Diamond coarse Ø5.0 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K Diamond coarse Ø4.0 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-150 80K steel Ø3 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-125 80K steel Ø7.0 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-125 80K steel Ø3 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-125 80K steel Ø2 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-125 80K steel Ø1 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-95 80K steel Ø3 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-95 80K steel Ø2 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø5.0x80 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø4.0x80 sterile 2026-02-19
Bien-Air Surgery SA
Bur PM2-70 80K steel Ø3.5x80 sterile 2026-02-19
Bien-Air Surgery SA
PM2-Nose MIS P160 1502938-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS P160 diam Ø4.0 St 1100683-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS P160 diam Ø3.0 St 1100682-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS P160 diam Ø2.0 St 1100681-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS P160 steel Ø4.0 St 1100680-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS P160 steel Ø3.0 St 1100679-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS P160 steel Ø2.0 St 1100678-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 diam C Ø4.0 St 1100677-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 diam C Ø2.0St 1100676-0012025-03-31
Bien-Air Surgery SA
PM2-Nose MIS D150 1502375-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 diam Ø4.0 St 1100512-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 steel Ø4.0 St 1100511-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 diam C Ø3.0 St 1100504-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 Mstick Ø3.0 St 1100503-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 Mstick Ø1.8 St 1100502-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 diam Ø3.0 St 1100501-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 diam Ø2.0 St 1100500-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 steel Ø3.0 St 1100499-0012025-03-31
Bien-Air Surgery SA
Bur PM2-MIS D150 steel Ø2.0 St 1100498-0012025-03-31
Bien-Air Surgery SA
PM2-S MIS 1601028-0012025-03-31
Bien-Air Surgery SA
ORiGO System2022-11-02
BIEN-AIR SURGERY SA
Sterile Stainless Steel Bur for PM22018-07-05
BIEN-AIR SURGERY SA
Sterile Diamond Bur for PM22018-07-05
BIEN-AIR SURGERY SA
RAPIDO Micromotor2018-07-05
BIEN-AIR SURGERY SA
PM2 - S70HD Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - S70 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - S150 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - S125 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A95 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A70HD Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A70 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A150 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A125 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PERFO Motorized Handpiece2018-07-05
BIEN-AIR SURGERY SA
OSSEODUO Control Unit2018-07-05
BIEN-AIR SURGERY SA
NANO Micromotor2018-07-05
BIEN-AIR SURGERY SA
Lubrifluid2018-07-05
BIEN-AIR SURGERY SA
Foot Pedal2018-07-05
BIEN-AIR SURGERY SA
Cranio Guard2018-07-05
BIEN-AIR SURGERY SA
Aquacare2018-07-05
BIEN-AIR SURGERY SA
Sterile Stainless Steel Bur for PM22018-07-05
BIEN-AIR SURGERY SA
Sterile Diamond Bur for PM22018-07-05
BIEN-AIR SURGERY SA
RAPIDO Micromotor2018-07-05
BIEN-AIR SURGERY SA
PM2 - S70HD Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - S70 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - S150 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - S125 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A95 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A70HD Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A70 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A150 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PM2 - A125 Handpiece2018-07-05
BIEN-AIR SURGERY SA
PERFO Motorized Handpiece2018-07-05
BIEN-AIR SURGERY SA
OSSEODUO Control Unit2018-07-05
BIEN-AIR SURGERY SA
NANO Micromotor2018-07-05
BIEN-AIR SURGERY SA
Lubrifluid2018-07-05
BIEN-AIR SURGERY SA
Foot Pedal2018-07-05
BIEN-AIR SURGERY SA
Cranio Guard2018-07-05
BIEN-AIR SURGERY SA
Aquacare2018-07-05
Bien-Air Surgery SA
OSSEODUO Shaver And Drill System2018-06-22
BIEN-AIR SURGERY SA
OSSEOSTAP Motorized Handpiece2016-02-23
BIEN-AIR SURGERY SA
OSSEOSTAP FootControl Unit2016-02-23
Bien-Air Surgery SA
OSSEOSTAP Microdrill System (control Unit And Handpiece), OSSEOSTAP Control Unit (foot Pedal), OSSEOSTAP Handpiece2015-03-04
BIEN-AIR SURGERY SA
Midas Rex2012-12-20
BIEN-AIR SURGERY SA
Irrigation Socket2011-09-20
BIEN-AIR SURGERY SA
Irrigation Line2011-09-20
BIEN-AIR SURGERY SA
Irrigation Clip2011-09-20
BIEN-AIR SURGERY SA
Sterilization Tray2010-05-05
BIEN-AIR SURGERY SA
Sterilization Tray S80/S1202010-05-05
BIEN-AIR SURGERY SA
Sterilization Tray Rhinoplasty2010-05-05
BIEN-AIR SURGERY SA
Sterilization Tray PM2 Neuro2010-05-05
BIEN-AIR SURGERY SA
Sterilization Tray PM2 ENT2010-05-05
BIEN-AIR SURGERY SA
Sterilization Tray OSSEOSTAP2010-05-05
BIEN-AIR SURGERY SA
Bur Holder2010-05-05
BIEN-AIR SURGERY SA
S80 Shaver Handpiece2009-03-24
BIEN-AIR SURGERY SA
S120 Shaver Handpiece2009-03-24
BIEN-AIR SURGERY SA
RAPIDO Micromotor2009-03-24
BIEN-AIR SURGERY SA
OSSEOUNO Control Unit2009-03-24
BIEN-AIR SURGERY SA
OSSEODUO Control Unit2009-03-24
BIEN-AIR SURGERY SA
NANO Micromotor2009-03-24
BIEN-AIR SURGERY SA
Foot Pedal2009-03-24
BIEN-AIR SURGERY SA
Cable for S80 Handpiece2009-03-24
BIEN-AIR SURGERY SA
Cable for S120 Handpiece2009-03-24
BIEN-AIR SURGERY SA
Cable for RAPIDO Micromotor2009-03-24
BIEN-AIR SURGERY SA
Cable for NANO Micromotor2009-03-24
BIEN-AIR SURGERY SA
Cable for 80k Micromotor2009-03-24
BIEN-AIR SURGERY SA
80k Micromotor2009-03-24
BIEN-AIR SURGERY SA
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K2009-03-20
BIEN-AIR SURGERY SA
Sagittal Micro Saw2008-04-02
BIEN-AIR SURGERY SA
Osseoscalpel Micro Saw2008-04-02
BIEN-AIR SURGERY SA
Oscillating Micro Saw2008-04-02
BIEN-AIR SURGERY SA
Micro wrench2008-04-02
BIEN-AIR SURGERY SA
Compass Micro Saw2008-04-02
BIEN-AIR SURGERY SA
Blade for sagittal micro saw2008-04-02
BIEN-AIR SURGERY SA
Blade for osseoscalpel micro saw2008-04-02
BIEN-AIR SURGERY SA
Blade for oscillating micro saw2008-04-02
BIEN-AIR SURGERY SA
Blade for compass micro saw2008-04-02
BIEN-AIR SURGERY SA
PM2 - S70HD Handpiece2008-02-08
BIEN-AIR SURGERY SA
PM2 - S70 Handpiece2008-02-08
BIEN-AIR SURGERY SA
PM2 - A95 Handpiece2008-02-08
BIEN-AIR SURGERY SA
PM2 - A70HD Handpiece2008-02-08
BIEN-AIR SURGERY SA
PM2 - A70 handpiece2008-02-08
BIEN-AIR SURGERY SA
PM2 - A150 Handpiece2008-02-08
BIEN-AIR SURGERY SA
PM2 - A125 Handpiece2008-02-08
BIEN-AIR SURGERY SA
OSSEODOC Foot Pedal2008-02-08
BIEN-AIR SURGERY SA
OSSEODOC Control Unit2008-02-08
BIEN-AIR SURGERY SA
Lubrifluid2008-02-08
BIEN-AIR SURGERY SA
Handpiece PMRM 11242008-02-08
BIEN-AIR SURGERY SA
Handpiece PMRM 11222008-02-08
BIEN-AIR SURGERY SA
Handpiece PMAM 12212008-02-08
BIEN-AIR SURGERY SA
Handpiece PMAM 11222008-02-08
BIEN-AIR SURGERY SA
Handpiece PMAM 101212008-02-08
BIEN-AIR SURGERY SA
Handpiece PM Fisch2008-02-08
BIEN-AIR SURGERY SA
Cable for BASCH-1 Micromotor2008-02-08
BIEN-AIR SURGERY SA
Cable for BASCH Micromotor2008-02-08
BIEN-AIR SURGERY SA
BASCH-1 Micromotor2008-02-08
BIEN-AIR SURGERY SA
BASCH Micromotor2008-02-08
BIEN-AIR SURGERY SA
Aquacare2008-02-08
BIEN-AIR SURGERY SA
Sterile Stainless Steel Bur2008-01-08
BIEN-AIR SURGERY SA
Sterile Stainless Steel Bur for PM22008-01-08
BIEN-AIR SURGERY SA
Sterile Stainless Steel Bur for OSSEOSTAP2008-01-08
BIEN-AIR SURGERY SA
Sterile Shaver Blade2008-01-08
BIEN-AIR SURGERY SA
Sterile Reusable Shaver Blade2008-01-08
BIEN-AIR SURGERY SA
Sterile Diamond Bur2008-01-08
BIEN-AIR SURGERY SA
Sterile Diamond Bur for PM22008-01-08
BIEN-AIR SURGERY SA
Sterile Diamond Bur for OSSEOSTAP2008-01-08
BIEN-AIR SURGERY SA
Sterile Carbide Bur2008-01-08
BIEN-AIR SURGERY SA
Sterile Carbide Bur for PM22008-01-08
BIEN-AIR SURGERY SA
Sterile Carbide Bur for OSSEOSTAP2008-01-08
BIEN-AIR SURGERY SA
Stainless Steel Bur2008-01-08
BIEN-AIR SURGERY SA
Stainless Steel Bur for PM22008-01-08
BIEN-AIR SURGERY SA
Diamond Bur2008-01-08
BIEN-AIR SURGERY SA
Diamond Bur for PM22008-01-08
BIEN-AIR SURGERY SA
Carbide Bur2008-01-08
BIEN-AIR SURGERY SA
Carbide Bur for PM22008-01-08

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