Biosphere Medical, S.A.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 18
- Inspections
- 5
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250971 | Embosphere Microspheres | May 16, 2025 |
| K192480 | Torpedo Gelatin Foam | November 21, 2019 |
| K183120 | EmboCube Embolization Gelatin | August 6, 2019 |
| K183578 | Torpedo Gelatin Foam | June 18, 2019 |
| K181021 | EmboCube Embolization Gelatin | September 27, 2018 |
| K181300 | Embosphere Microspheres | July 16, 2018 |
| K172372 | QuadraSphere Microspheres | September 6, 2017 |
| DEN160040 | Embosphere Microspheres | June 21, 2017 |
| K153102 | QuadraSphere Microspheres | November 23, 2015 |
| K151187 | QuadraSphere Microspheres | July 27, 2015 |
| K113822 | QUADRASPHERE 30 TO 60 | March 8, 2012 |
| K052742 | HEPASPHERE MICROSPHERES | November 7, 2006 |
| K062126 | EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 | August 9, 2006 |
| K061171 | SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX | June 2, 2006 |
| K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION | November 22, 2002 |
| K010026 | EMBOGOLD MICROSPHERE | June 21, 2001 |
| K003105 | BIOSPHERE MEDICAL INFUSION CATHETER | May 22, 2001 |
| K991549 | EMBOSPHERE MICROSPHERES | April 26, 2000 |