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 Number: 9615728
• FEI Number: 3002808761
• Name: BIOSPHERE MEDICAL SA
• Owner & Operator: Merit Medical Systems, Inc.
• Contact Address: 1600 West Merit Parkway --; South Jordan UT 84095 US
• US Agent:
  • JOHN KNORPP
  • MERIT MEDICAL SYSTEMS, INC
  • 801 2084389
  • 801 8264157
  • jknorpp@merit.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Parc 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	Device	Date
PMN K192480 Biosphere Medical, S.A.	Torpedo Gelatin Foam	2019-11-21
PMN K183120 | KRD BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	EmboCube Gelatin Embolization	2019-08-16
PMN K183120 Biosphere Medical, S.A.	EmboCube Embolization Gelatin	2019-08-06
PMN K183578 | KRD BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	Torpedo Gelatin Foam	2019-06-25
PMN K183578 Biosphere Medical, S.A.	Torpedo Gelatin Foam	2019-06-18
PMN K181021 | KRD BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	EmboCube Embolization Gelatin	2018-10-03
PMN K181021 Biosphere Medical, S.A.	EmboCube Embolization Gelatin	2018-09-27
PMN K181300 Biosphere Medical, S.A.	Embosphere Microspheres	2018-07-16
PMN K172372 | KRD BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	QuadraSphere Q2 Microspheres	2017-09-08
PMN K172372 | KRD BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	QuadraSphere Microspheres	2017-09-08
PMN K172372 | HCG BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	QuadraSphere Q2 Microspheres	2017-09-08
PMN K172372 | HCG BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	QuadraSphere Microspheres	2017-09-08
PMN DEN160040 | NOY BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	Embosphere Microspheres	2017-09-08
PMN DEN160040 | NOY BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	Emboshpere PRO	2017-09-08
PMN K172372 Biosphere Medical, S.A.	QuadraSphere Microspheres	2017-09-06
De Novo DEN160040 Biosphere Medical S.A.	Embosphere Microspheres	2017-06-21
PMN K153102 | KRD BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	QuadraSphere Microspheres	2017-01-26
PMN K153102 | HCG BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	QuadraSphere Microspheres	2017-01-26
PMN K062126 | DQO BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	EmboCath Plus infusion Microcatheter	2017-01-26
PMN K061171 | DQX BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	Tenor Steerable Guidewire	2017-01-26
PMN K061171 | DQX BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	Sequitor Steerable Guidewire	2017-01-26
PMN K021397 | NAJ BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	Emboshpere Microspheres	2017-01-26
PMN K010026 | HCG BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	EmboGold Microspheres	2017-01-26
PMN K153102 BIOSPHERE MEDICAL, S.A.	QuadraSphere Microspheres	2015-11-23
PMN K151187 BIOSPHERE MEDICAL S.A.	QuadraSphere Microspheres	2015-07-27
PMN K130259 | NAJ BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	Bearing nsPVA Embolization Particles	2013-06-20
PMN K130259 | KRD BIOSPHERE MEDICAL SA [Merit Medical Systems, Inc.]	Bearing nsPVA Embolization Particles	2013-06-20