Data / Medical devices / Dominican Republic / Baxter Healthcare, S.A.
Baxter Healthcare, S.A.: FDA-registered device maker in Haina San Cristobal, Dominican Republic, 35 510(k) clearances
Baxter Healthcare, S.A. is registered with the FDA (registration 9612052) in Haina San Cristobal, Dominican Republic. It lists 13 device types. The FDA files 35 510(k) clearances under its listings, the newest dated March 14, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9612052
- FEI number
- 3002806443
- Address
- Parque Industrial ITABO Carretera Sanchez KM 18 1/2 Buildings 48, 49, and 50, Haina San Cristobal, Dominican Republic, 21426
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 31, 1991
- Registered through
- 2026
- Brand names listed
- 3 Lead Ext w/2 Interlink Inject Sit, 3 Port Adapter, ADAPTACAP, AUTOMIX 3+3 COMPOUNDER, Abacus, All-In-One Two Chamber Container, Arthromatic, Arthroscopic Irrigation Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Administrations Sets With Neuraxial Connectors | PWH | 2 | Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Filter, Infusion Line | FPB | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Set, Blood Transfusion | BRZ | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 2 | Manufacturer | accessdata.fda.gov |
| System, Hemodialysis, Remote Accessories | MON | 1 | Contract manufacturer | accessdata.fda.gov |
| System, Irrigation, Urological | LJH | 2 | Manufacturer | accessdata.fda.gov |
| System, Peritoneal, Automatic Delivery | FKX | 2 | Contract manufacturer | accessdata.fda.gov |
| System/Device, Pharmacy Compounding | NEP | 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 |
|---|---|---|---|---|---|---|
| March 14, 2025 | K243529 | Solution Administration Sets | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| February 28, 2025 | K242339 | Intravascular Extension Sets and Accessories | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| March 10, 2023 | K223175 | lntravascular Administration Sets with Stopcock and Manifold | FMG | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| November 17, 2022 | K220558 | Blood Administration Sets | BRZ | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| October 3, 2022 | K212262 | PCA Syringe Sets | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| November 23, 2021 | K211649 | PCEA Syringe Set | PWH | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| September 30, 2021 | K203609 | Intravascular Administration Sets | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| June 18, 2021 | K210430 | Intravascular Extension Set | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| June 10, 2021 | K210335 | Blood Administration Set | BRZ | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| May 28, 2019 | K180739 | Clearlink System Solution Set | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| November 30, 2016 | K161323 | Solution Set for Epidural Use | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| December 28, 2015 | K153158 | Solution Administration Sets with 0.2 Micron Filter | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| August 18, 2014 | K142011 | SOLUTION SET/EXTENSION SET | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| October 8, 2013 | K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 1, 2013 | K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | FMG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 10, 2013 | K123874 | INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 8, 2013 | K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 29, 2012 | K121634 | INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| December 8, 2011 | K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | FPB | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| October 18, 2011 | K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| December 20, 2000 | K003730 | CHEMO-AIDE DISPENSING PIN | LHI | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| November 17, 1999 | K993120 | MODIFIED BLOOD RECIPIENT SET | BRZ | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| August 17, 1998 | K981792 | SOLUTION ADMINISTRATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 31, 1997 | K964853 | INTRAVIA CONTAINER, EMPTY | KPE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 21, 1996 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 14, 1996 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | LJH | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| August 3, 1993 | K925058 | BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET | FPA | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 18, 1993 | K925126 | INTERLINK(TM) INJECTION SITE | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 21, 1993 | K924064 | INTERLINK UNIVERSAL VIAL ADAPTER | LHI | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 20, 1993 | K921899 | INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 12, 1992 | K915390 | 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| September 23, 1991 | K913627 | 3 PORT ADAPTER | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 17, 1987 | K870940 | SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC. | FPA | Substantially Equivalent | Travenol Laboratories, S.A. | accessdata.fda.gov |
| July 2, 1981 | K811078 | RADIATION STERILIZED ADMIN. SET | FPA | Substantially Equivalent | Travenol Laboratories, S.A. | accessdata.fda.gov |
| April 8, 1980 | K791496 | LOW PLASTICIZER ADMINISTRATION SETS | FPA | Substantially Equivalent | Travenol Laboratories, S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Irrigation, Urological
- All makers of Set, Administration, Intravascular
- All makers of Set, Blood Transfusion
- All makers of System/Device, Pharmacy Compounding
- All makers of Set, I.V. Fluid Transfer
- All makers of Arthroscope
Updated March 14, 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.