Company ยท FR
Biosphere Medical, S.A.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2025. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 2025 | K250971 | Embosphere Microspheres Biosphere Medical, S.A., FR | KRD |
| Nov 21, 2019 | K192480 | Torpedo Gelatin Foam Biosphere Medical, S.A., FR | KRD |
| Aug 6, 2019 | K183120 | EmboCube Embolization Gelatin Biosphere Medical, S.A., FR | KRD |
| Jun 18, 2019 | K183578 | Torpedo Gelatin Foam Biosphere Medical, S.A., FR | KRD |
| Sep 27, 2018 | K181021 | EmboCube Embolization Gelatin Biosphere Medical, S.A., FR | KRD |
| Jul 16, 2018 | K181300 | Embosphere Microspheres Biosphere Medical, S.A., FR | KRD |
| Sep 6, 2017 | K172372 | QuadraSphere Microspheres Biosphere Medical, S.A., FR | KRD |
| Jun 21, 2017 | DEN160040 | Embosphere Microspheres Biosphere Medical, S.A., FR | NOY |
| Nov 23, 2015 | K153102 | QuadraSphere Microspheres Biosphere Medical, S.A., FR | KRD |
| Jul 27, 2015 | K151187 | QuadraSphere Microspheres Biosphere Medical, S.A., FR | KRD |
| Mar 8, 2012 | K113822 | QUADRASPHERE 30 TO 60 Biosphere Medical, Inc. | HCG |
| Nov 7, 2006 | K052742 | HEPASPHERE MICROSPHERES Biosphere Medical, Inc. | KRD |
| Aug 9, 2006 | K062126 | EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 Biosphere Medical, Inc. | DQO |
| Jun 2, 2006 | K061171 | SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX Biosphere Medical, Inc. | DQX |
| Nov 22, 2002 | K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION Biosphere Medical, Inc. | NAJ |
| Jun 21, 2001 | K010026 | EMBOGOLD MICROSPHERE Biosphere Medical, Inc. | HCG |
| May 22, 2001 | K003105 | BIOSPHERE MEDICAL INFUSION CATHETER Biosphere Medical | DQO |
| Apr 26, 2000 | K991549 | EMBOSPHERE MICROSPHERES Biosphere Medical | HCG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||