Data / Medical devices / Costa Rica / Baxter Productos Medicos, Ltda.

Baxter Productos Medicos, Ltda.: FDA-registered device maker in 1-7052 Cartago, Costa Rica, 21 510(k) clearances

Name: Baxter Productos Medicos, Ltda. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Baxter Productos Medicos, Ltda. is registered with the FDA (registration 8040700) in 1-7052 Cartago, Costa Rica. It lists 8 device types. The FDA files 21 510(k) clearances under its listings, the newest dated March 14, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8040700
FEI number: 3002806588
Address: Parque Industrial De Cartago Apartado, 1-7052 Cartago, Costa Rica, --
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Manufacturer
First device listed: July 10, 1997
Registered through: 2026
Brand names listed: 3 Lead Ext w/2 Interlink Inject Sit, AUTOMIX 3+3 COMPOUNDER, Abacus, All-In-One Two Chamber Container, Arthromatic, Arthroscopic Irrigation Set, Automix 3+3/AS Compounder System, Bard Epidural Spike Tubing Set and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	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
Stopcock, I.V. Set	FMG	2	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Manufacturer	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	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
September 30, 2021	K203609	Intravascular Administration Sets	FPA	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
September 22, 2017	K172544	IV Fat Emulsion Administration Sets	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
April 16, 2015	K150860	Nitroglycerin Sets with DUO-VENT Spike	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 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
October 18, 2011	K112893	CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
October 19, 2000	K003225	SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE	FPA	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
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
July 27, 1995	K952074	SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
June 18, 1993	K925126	INTERLINK(TM) INJECTION SITE	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
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

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.