Data / Medical devices / Belgium / Baxter R&D Europe SRL
Baxter R&D Europe SRL: FDA-registered device maker in Braine-l'Alleud Wallonia, Belgium, 1 510(k) clearance and 2 PMA approvals
Baxter R&D Europe SRL is registered with the FDA (registration 1000359047) in Braine-l'Alleud Wallonia, Belgium. It lists 5 device types. The FDA files 1 510(k) clearance and 2 PMA approvals under its listings, the newest dated July 28, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000359047
- Address
- Boulevard d'Angleterre 2-4, Braine-l'Alleud Wallonia, Belgium, 1420
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Specification developer
- First device listed
- January 22, 2015
- Registered through
- 2026
- Brand names listed
- ARS-530 Air Regulator System, Adept, Coseal Surgical Sealant, Due Set A, Duo Set, Duploject, EasySpray, Fibrinotherm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Absorbable, Adhesion | MCN | 3 | Specification developer | accessdata.fda.gov |
| Block, Heating | JRG | 1 | Specification developer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Specification developer | accessdata.fda.gov |
| Sealant, Polymerizing | NBE | 3 | Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 2, 2005 | K050495 | EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) | FMF | Substantially Equivalent | Baxter Healthcare Corp., Bioscience | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 28, 2006 | P050011 | ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION | MCN | 9 | August 23, 2024 | accessdata.fda.gov |
| December 12, 2003 | P030039 | COSEAL SURGICAL SEALANT | NBE | 28 | December 18, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Syringe, Piston
- All makers of Sealant, Polymerizing
- All makers of Barrier, Absorbable, Adhesion
- All makers of Block, Heating
Updated August 23, 2024. 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.