Biosphere Medical S A

FDA Filings

This page includes the latest FDA filings for Biosphere Medical 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 Number9615728
FEI Number3002808761
NameBIOSPHERE MEDICAL SA
Owner & OperatorMerit Medical Systems, Inc.
Contact Address1600 West Merit Parkway --
South Jordan UT 84095 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressParc des Nations - Paris Nord 2, 383 rue de la Belle Etoile 95700 ROISSY EN FRANCE FRA
Roissy Val-dOise, 95700 FR
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Biosphere Medical, S.A.
Torpedo Gelatin Foam2019-11-21
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
EmboCube Gelatin Embolization2019-08-16
Biosphere Medical, S.A.
EmboCube Embolization Gelatin2019-08-06
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
Torpedo Gelatin Foam2019-06-25
Biosphere Medical, S.A.
Torpedo Gelatin Foam2019-06-18
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
EmboCube Embolization Gelatin2018-10-03
Biosphere Medical, S.A.
EmboCube Embolization Gelatin2018-09-27
Biosphere Medical, S.A.
Embosphere Microspheres2018-07-16
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
QuadraSphere Q2 Microspheres2017-09-08
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
QuadraSphere Microspheres2017-09-08
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
QuadraSphere Q2 Microspheres2017-09-08
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
QuadraSphere Microspheres2017-09-08
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
Embosphere Microspheres2017-09-08
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
Emboshpere PRO2017-09-08
Biosphere Medical, S.A.
QuadraSphere Microspheres2017-09-06
Biosphere Medical S.A.
Embosphere Microspheres2017-06-21
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
QuadraSphere Microspheres2017-01-26
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
QuadraSphere Microspheres2017-01-26
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
EmboCath Plus infusion Microcatheter2017-01-26
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
Tenor Steerable Guidewire2017-01-26
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
Sequitor Steerable Guidewire2017-01-26
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
Emboshpere Microspheres2017-01-26
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
EmboGold Microspheres2017-01-26
BIOSPHERE MEDICAL, S.A.
QuadraSphere Microspheres2015-11-23
BIOSPHERE MEDICAL S.A.
QuadraSphere Microspheres2015-07-27
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
Bearing nsPVA Embolization Particles2013-06-20
BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]
Bearing nsPVA Embolization Particles2013-06-20

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