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 PM2-125 80K Diam EC Ø6.0 St 1101253-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam EC Ø6.0 St 1101252-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam EC Ø4.7 St 1101242-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam EC Ø3.8 St 1101241-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam EC Ø4.7 St 1101197-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam EC Ø3.8 St 1101196-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam Ø4.0 St 1101192-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam Ø3.1 St 1101191-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam Ø2.3 St 1101190-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam Ø1.8 St 1101189-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam Ø1.0 St 1101188-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam Ø1.0 St 1101198-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam Ø1.8 St 1101199-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam Ø2.3 St 1101200-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam Ø3.1 St 1101201-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam Ø4.0 St 1101202-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Diam Ø1.0 St 1101207-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Diam Ø1.8 St 1101208-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Diam Ø3.1 St 1101209-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Diam Ø4.0 St 1101210-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Diam C Ø5.0 St 1101213-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Diam C Ø4.0 St 1101212-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Diam C Ø3.1 St 1101211-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam C Ø6.0 St 1101206-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam C Ø5.0 St 1101205-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam C Ø4.0 St 1101204-0012024-12-12
Bien-Air Surgery SA
Bur PM2-95 80K Diam C Ø3.1 St 1101203-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam C Ø5.0 St 1101195-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam C Ø4.0 St 1101194-0012024-12-12
Bien-Air Surgery SA
Bur PM2-125 80K Diam C Ø3.1 St 1101193-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Mstick Ø1.8 St 1101250-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Mstick Ø3.0 St 1101251-0012024-12-12
Bien-Air Surgery SA
Bur Cranial Straight 10mm St 1101234-0012024-12-12
Bien-Air Surgery SA
Bur Cranial Spiral 10mm St 1101235-0012024-12-12
Bien-Air Surgery SA
Bur Cranial Spiral 25mm St 1101239-0012024-12-12
Bien-Air Surgery SA
Bur Cranial Straight 25 mm St 1101240-0012024-12-12
Bien-Air Surgery SA
Bur PM2 80K Steel TD Ø1.1x4 St 1101247-0012024-12-12
Bien-Air Surgery SA
Bur PM2 80K Steel TD Ø1.1x5 St 1101248-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Steel Ø3.1 St 1101214-0012024-12-12
Bien-Air Surgery SA
Bur PM2-150 80K Steel Ø4.0 St 1101215-0012024-12-12
Bien-Air Surgery SA
RA XL Ø2.35x34 Zekrya 1100870-0012024-12-09
Bien-Air Surgery SA
RA L Ø2.35x26 Zekrya 1100869-0012024-12-09
Bien-Air Surgery SA
RA XL Ø2.35x34 Lindemann 1100868-0012024-12-09
Bien-Air Surgery SA
RA L Ø2.35x26 Lindemann 1100867-0012024-12-09
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø6.0 St 1101233-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam EC Ø4.5 St 1101232-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø7.0 St 1101229-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø6.0 St 1101228-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø5.0 St 1101227-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø4.5 St 1101226-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø4.0 St 1101225-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø3.5 St 1101224-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø3.1 St 1101223-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø2.7 St 1101222-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø2.3 St 1101221-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø1.8 St 1101220-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø1.4 St 1101219-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø1.0 St 1101218-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam C Ø3.1 St 1101231-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam C Ø2.3 St 1101230-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø0.8 St 1101217-0012024-04-09
Bien-Air Surgery SA
Bur PM2-70 80K diam Ø0.6 St 1101216-0012024-04-09
Bien-Air Surgery SA
Bur PM2-150 80K Matchstick Ø3.0mm sterile 1100482-0012023-12-04
Bien-Air Surgery SA
ShBlade 120°concv Ø4.0mm DS St 2023-07-31
Bien-Air Surgery SA
ShBlade 90°concv Ø4.0mm DS St 2023-07-31
Bien-Air Surgery SA
Compass Microsaw G2 2023-07-31
Bien-Air Surgery SA
Oscillating Microsaw G2 2023-07-31
Bien-Air Surgery SA
Osseoscalpel Microsaw G2 2023-07-31
Bien-Air Surgery SA
High-Speed Micro-Motor, large 1700763-0012023-03-27
Bien-Air Surgery SA
High-Speed Micro-Motor, small 1700762-0012023-03-27
Bien-Air Surgery SA
Perforator Handpiece 1700761-0012023-03-27
Bien-Air Surgery SA
Tungst.Carb.Burr,Ø3.5x70mm,50k 1100534-0012023-03-02
Bien-Air Surgery SA
Tungst.Carb.Burr,Ø3.1x70mm,50k 1100533-0012023-03-02
Bien-Air Surgery SA
Tungst.Carb.Burr,Ø2.7x70mm,50k 1100532-0012023-03-02
Bien-Air Surgery SA
Tungst.Carb.Burr,Ø2.3x70mm,50k 1100531-0012023-03-02
Bien-Air Surgery SA
Tungst.Carb.Burr,Ø1.8x70mm,50k 1100530-0012023-03-02
Bien-Air Surgery SA
Tungst.Carb.Burr,Ø1.4x70mm,50k 1100529-0012023-03-02
Bien-Air Surgery SA
Tungst.Carb.Burr,Ø1.0x70mm,50k 1100528-0012023-03-02
Bien-Air Surgery SA
Tungst.Carb.Burr,Ø0.8x70mm,50k 1100527-0012023-03-02
Bien-Air Surgery SA
Tungst.Carb.Burr,Ø0.5x70mm,50k 1100526-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø7.0x70, 50k 1100525-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø6.0x70, 50k 1100524-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø5.0x70, 50k 1100523-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø4.0x70, 50k 1100522-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø3.5x70, 50k 1100521-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø3.1x70, 50k 1100520-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø2.7x70, 50k 1100519-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø2.3x70, 50k 1100518-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø1.8x70, 50k 1100517-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø1.4x70, 50k 1100516-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø1.0x70, 50k 1100515-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø0.8x70, 50k 1100514-0012023-03-02
Bien-Air Surgery SA
HS Diam. Burr, Ø0.6x70, 50k 1100513-0012023-03-02
Bien-Air Surgery SA
Micro Ear Drill, 12k 1601126-0012023-03-02
Bien-Air Surgery SA
HS-Handpiece,angled,150mm,80k 1601109-0012023-03-02
Bien-Air Surgery SA
HS-Handpiece, angled,125mm,80k 1601108-0012023-03-02
Bien-Air Surgery SA
HS-Handpiece,angled,95mm,80k 1601107-0012023-03-02
Bien-Air Surgery SA
HS-Handpiece,angled,70mm,80k 1601106-0012023-03-02
Bien-Air Surgery SA
HS-Handpiece,angled,70mm,80k 1601105-0012023-03-02
Bien-Air Surgery SA
HS-Handpiece,straight,70mm,80k 1601104-0012023-03-02
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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