Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Biosphere Medical, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K113822 QUADRASPHERE 30 TO 60HCG2012-03-08 View
510(k) K052742 HEPASPHERE MICROSPHERESKRD2006-11-07 View
510(k) K062126 EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135DQO2006-08-09 View
510(k) K061171 SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XXDQX2006-06-02 View
510(k) K021397 EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATIONNAJ2002-11-22 View
510(k) K010026 EMBOGOLD MICROSPHEREHCG2001-06-21 View
↑