Biosphere Medical, S.A.
FranceFDA applicant, unverified FDA FEI 3002808761
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
EmboCube Embolization Gelatin Ref K183120
Regimes: 510(k) Registry: 510(k)Embosphere Microspheres Ref DEN160040
Regimes: De Novo Registry: 510(k)Torpedo Gelatin Foam Ref K183578
Regimes: 510(k) Registry: 510(k)Embosphere Microspheres Ref K250971
Regimes: 510(k) Registry: 510(k)QuadraSphere Microspheres Ref K151187
Regimes: 510(k) Registry: 510(k)QuadraSphere Microspheres Ref K153102
Regimes: 510(k) Registry: 510(k)Embosphere Microspheres Ref K181300
Regimes: 510(k) Registry: 510(k)QuadraSphere Microspheres Ref K172372
Regimes: 510(k) Registry: 510(k)EmboCube Embolization Gelatin Ref K181021
Regimes: 510(k) Registry: 510(k)Torpedo Gelatin Foam Ref K192480
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002808761
- Address
- Parc des Nations - Paris Nord 2, 383 rue de la Belle Etoile, Roissy Val-d'Oise
Frequently asked questions
How many devices does Biosphere Medical, S.A. have in the registry?
The registry currently lists 10 devices for Biosphere Medical, S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosphere Medical, S.A.'s devices?
Among its 10 most recently registered devices, Biosphere Medical, S.A. has devices listed in FDA 510(k) (10 devices).
What risk classes do Biosphere Medical, S.A.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Biosphere Medical, S.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosphere Medical, S.A. in the registry?
The most recently registered devices listed for Biosphere Medical, S.A. include EmboCube Embolization Gelatin, Embosphere Microspheres, Torpedo Gelatin Foam and QuadraSphere Microspheres.