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Biosphere Medical, S.A.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories1
Latest FDA decision2025-05-16
TypeNumberDevice NameCodeDateActions
510(k) K250971 Embosphere MicrospheresKRD2025-05-16 View
510(k) K192480 Torpedo Gelatin FoamKRD2019-11-21 View
510(k) K183120 EmboCube Embolization GelatinKRD2019-08-06 View
510(k) K183578 Torpedo Gelatin FoamKRD2019-06-18 View
510(k) K181021 EmboCube Embolization GelatinKRD2018-09-27 View
510(k) K181300 Embosphere MicrospheresKRD2018-07-16 View
510(k) K172372 QuadraSphere MicrospheresKRD2017-09-06 View