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
ORiGO System2022-11-02
Bien-Air Surgery SA
Long microsaw blade 25x0,6mm 1502682-0012021-03-02
Bien-Air Surgery SA
Long microsaw blade 21x0,6mm 1502681-0012021-03-02
Bien-Air Surgery SA
Long microsaw blade 17x0,6mm 1502680-0012021-03-02
Bien-Air Surgery SA
Long microsaw blade 25x0,4mm 1502679-0012021-03-02
Bien-Air Surgery SA
Long microsaw blade 21x0,4mm 1502678-0012021-03-02
Bien-Air Surgery SA
Long microsaw blade 17x0.4mm 1502677-0012021-03-02
Bien-Air Surgery SA
Short microsaw blade 25x0.6mm 1502676-0012021-03-02
Bien-Air Surgery SA
Short microsaw blade 21x0.6mm 1502675-0012021-03-02
Bien-Air Surgery SA
Short microsaw blade 17x0.6mm 1502674-0012021-03-02
Bien-Air Surgery SA
Short microsaw blade 25x0.4mm 1502673-0012021-03-02
Bien-Air Surgery SA
Short microsaw blade 21x0.4mm 1502672-0012021-03-02
Bien-Air Surgery SA
Short microsaw blade 17x0.4mm 1502671-0012021-03-02
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø4.5mm sterile 1100484-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø3.5mm sterile 1100483-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø7.0mm sterile 1100477-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø5.0mm sterile 1100476-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø0.5mm sterile 1100475-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø6.0mm sterile 1100468-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø4.0mm sterile 1100467-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø3.0mm sterile 1100466-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø2.3mm sterile 1100465-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø2.0mm sterile 1100464-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø1.5mm sterile 1100463-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K full carbide Ø1.0mm sterile 1100462-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K carbide conical Ø7.0mm sterile 1100431-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K carbide conical Ø6.0mm sterile 1100430-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø7.0mm sterile 1100429-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø6.0mm sterile 1100428-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø5.0mm sterile 1100427-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø4.5mm sterile 1100426-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø4.0mm sterile 1100425-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø3.5mm sterile 1100424-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø3.1mm sterile 1100423-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø2.7mm sterile 1100422-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø2.3mm sterile 1100421-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø1.8mm sterile 1100420-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø1.4mm sterile 1100419-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø1.0mm sterile 1100418-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø0.8mm sterile 1100417-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 50K steel Ø0.6mm sterile 1100416-0052020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø7.0mm sterile 1100405-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø6.0mm sterile 1100404-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø5.0mm sterile 1100403-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø4.5mm sterile 1100402-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø4.0mm sterile 1100401-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø3.5mm sterile 1100400-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø3.1mm sterile 1100399-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø2.7mm sterile 1100398-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø2.3mm sterile 1100397-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø1.8mm sterile 1100396-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø1.4mm sterile 1100395-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø1.0mm sterile 1100394-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø0.8mm sterile 1100393-0012020-06-08
Bien-Air Surgery SA
Bur PM2-70 80K carbide Ø0.5mm sterile 1100392-0012020-06-08
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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