Biosphere Medical, S.A. - FDA 510(k) Cleared Devices
10
Total
9
Cleared
1
Denied
5 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