Data / Medical devices / Belgium / Baxter SA
Baxter SA: FDA-registered device maker in LESSINES Hainaut, Belgium, 1 510(k) clearance and 1 PMA approval
Baxter SA is registered with the FDA (registration 8010130) in LESSINES Hainaut, Belgium. It lists 4 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated May 2, 2005. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8010130
- FEI number
- 3005468265
- Address
- Boulevard Rene Branquart, 80, LESSINES Hainaut, Belgium, 7860
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Manufacturer
- First device listed
- January 22, 2015
- Registered through
- 2027
- Brand names listed
- ARS-530 Air Regulator System, Coseal Surgical Sealant, Due Set A, Duo Set, Duploject, EasySpray, Fibrinotherm, Spray Set for Tisseel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Block, Heating | JRG | 1 | Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Manufacturer | accessdata.fda.gov |
| Sealant, Polymerizing | NBE | 3 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | 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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| December 12, 2003 | P030039 | COSEAL SURGICAL SEALANT | NBE | 28 | December 18, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Sealant, Polymerizing
- All makers of Block, Heating
Updated December 18, 2025. 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.