Biosphere Medical, S.A.
Roissy Val-d'Oise, FR
BIOSPHERE MEDICAL, S.A. appears in FDA device records in Roissy Val-d'Oise, FR. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Biosphere Medical, S.A. between 2000 and 2025. The busiest year on record is 2006, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2006 | 3 |
| 2012 | 1 |
| 2015 | 2 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250971 | Embosphere Microspheres | KRD | Substantially Equivalent | |
| K192480 | Torpedo Gelatin Foam | KRD | Substantially Equivalent | |
| K183120 | EmboCube Embolization Gelatin | KRD | Substantially Equivalent | |
| K183578 | Torpedo Gelatin Foam | KRD | Substantially Equivalent | |
| K181021 | EmboCube Embolization Gelatin | KRD | Substantially Equivalent | |
| K181300 | Embosphere Microspheres | KRD | Substantially Equivalent | |
| K172372 | QuadraSphere Microspheres | KRD | Substantially Equivalent | |
| DEN160040 | Embosphere Microspheres | NOY | Unknown | |
| K153102 | QuadraSphere Microspheres | KRD | Substantially Equivalent | |
| K151187 | QuadraSphere Microspheres | KRD | Substantially Equivalent | |
| K113822 | QUADRASPHERE 30 TO 60 | HCG | Substantially Equivalent | |
| K052742 | HEPASPHERE MICROSPHERES | KRD | Substantially Equivalent | |
| K062126 | EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 | DQO | Substantially Equivalent | |
| K061171 | SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX | DQX | Substantially Equivalent | |
| K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION | NAJ | Substantially Equivalent | |
| K010026 | EMBOGOLD MICROSPHERE | HCG | Substantially Equivalent | |
| K003105 | BIOSPHERE MEDICAL INFUSION CATHETER | DQO | Substantially Equivalent | |
| K991549 | EMBOSPHERE MICROSPHERES | HCG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615728 | 3002808761 | BIOSPHERE MEDICAL, S.A. | Parc des Nations - Paris Nord 2, 383 rue de la Belle Etoile, Roissy Val-d'Oise 95700 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Biosphere Medical, S.A. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain