Biosphere Medical, S.A. - FDA 510(k) Cleared Devices
10
Total
9
Cleared
1
Denied
Biosphere Medical, S.A. has 9 FDA 510(k) cleared medical devices. Based in Roissy-En-France, FR.
Latest FDA clearance: May 2025. Active since 2015. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Biosphere Medical, S.A. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Biosphere Medical, S.A.
10 devices
Cleared
May 16, 2025
Embosphere Microspheres
Cardiovascular
46d
Cleared
Nov 21, 2019
Torpedo Gelatin Foam
Cardiovascular
72d
Cleared
Aug 06, 2019
EmboCube Embolization Gelatin
Cardiovascular
270d
Cleared
Jun 18, 2019
Torpedo Gelatin Foam
Cardiovascular
179d
Cleared
Sep 27, 2018
EmboCube Embolization Gelatin
Cardiovascular
163d
Cleared
Jul 16, 2018
Embosphere Microspheres
Neurology
60d
Cleared
Sep 06, 2017
QuadraSphere Microspheres
Neurology
30d
Not Cleared
Jun 21, 2017
Embosphere Microspheres
Gastroenterology & Urology
320d
Cleared
Nov 23, 2015
QuadraSphere Microspheres
Neurology
28d
Cleared
Jul 27, 2015
QuadraSphere Microspheres
Neurology
84d