Data / Medical devices / France / Biosphere Medical, S.A.
Biosphere Medical, S.A.: FDA-registered device maker in Roissy Val-d'Oise, France, 5 510(k) clearances
Biosphere Medical, S.A. is registered with the FDA (registration 9615728) in Roissy Val-d'Oise, France. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 21, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615728
- FEI number
- 3002808761
- Address
- Parc des Nations - Paris Nord 2, 383 rue de la Belle Etoile 95700 ROISSY-EN-FRANCE, FRANCE, Roissy Val-d'Oise, France, 95700
- Owner or operator
- Merit Medical Systems, Inc. (1721504)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 20, 2013
- Registered through
- 2026
- Brand names listed
- Bearing nsPVA Embolization Particles, EmboCube Gelatin Embolization, EmboGold Microspheres, Embosphere Microspheres, QuadraSphere Microspheres, QuadraSphere Q2 Microspheres, Torpedo Gelatin Foam
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | NOY | 2 | Manufacturer | accessdata.fda.gov |
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Neurovascular Embolization | HCG | 2 | Manufacturer | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 21, 2019 | K192480 | Torpedo Gelatin Foam | KRD | Substantially Equivalent | Biosphere Medical, S.A. | accessdata.fda.gov |
| August 6, 2019 | K183120 | EmboCube Embolization Gelatin | KRD | Substantially Equivalent | Biosphere Medical, S.A. | accessdata.fda.gov |
| July 16, 2018 | K181300 | Embosphere Microspheres | KRD | Substantially Equivalent | Biosphere Medical, S.A. | accessdata.fda.gov |
| September 6, 2017 | K172372 | QuadraSphere Microspheres | KRD | Substantially Equivalent | Biosphere Medical, S.A. | accessdata.fda.gov |
| June 21, 2001 | K010026 | EMBOGOLD MICROSPHERE | HCG | Substantially Equivalent | Biosphere Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Neurovascular Embolization
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Agents, Embolic, For Treatment Of Uterine Fibroids
- All makers of Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Updated November 21, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.