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Data / Medical devices / United States / Baxter Healthcare of Puerto Rico LLC

Baxter Healthcare of Puerto Rico LLC: FDA-registered device maker in Aibonito, PR, United States, 9 510(k) clearances

Baxter Healthcare of Puerto Rico LLC is registered with the FDA (registration 2649614) in Aibonito, PR, United States. It lists 33 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 8, 2013. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Baxter Healthcare of Puerto Rico LLC
FDA registration number
2649614
Address
RD. 721, KM. 0.3, Aibonito, PR, United States, 00705
Owner or operator
BAXTER HEALTHCARE CORPORATION (1417572)
Roles
Contract sterilizer, Manufacturer
First device listed
December 1, 1988
Registered through
2027
Brand names listed
100mm Femoral Nozzle, 180 gr. Cartridge, 180 gr. Cartridge With Femoral Nozzle, 65 deg. Post. Fem. Press, Additive Cap, Ahto Cassette Tube Set, Ahto Cassette Tube Set with tip, Ahto Dual Spike Cassette Tube Set and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Contract sterilizeraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Contract sterilizeraccessdata.fda.gov
ArthroscopeHRX2Contract sterilizeraccessdata.fda.gov
Bit, DrillHTW1Contract sterilizeraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Contract sterilizeraccessdata.fda.gov
Bone CementLOD2Contract sterilizeraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Contract sterilizeraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Contract sterilizeraccessdata.fda.gov
Cement ObturatorLZN2Contract sterilizeraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Contract sterilizeraccessdata.fda.gov
Container, I.V.KPE2Manufactureraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Contract sterilizeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract sterilizeraccessdata.fda.gov
Evacuator, Gastro-UrologyKQT2Contract sterilizeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract sterilizeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Contract sterilizeraccessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)OAR1Contract sterilizeraccessdata.fda.gov
Instrument, BiopsyKNW2Contract sterilizeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract sterilizeraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract sterilizeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract sterilizeraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Contract sterilizeraccessdata.fda.gov
Lavage, JetFQH2Contract sterilizeraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Contract sterilizeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract sterilizeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract sterilizeraccessdata.fda.gov
Set, Administration, IntravascularFPA2Manufactureraccessdata.fda.gov
Set, I.V. Fluid TransferLHI2Manufactureraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Contract sterilizeraccessdata.fda.gov
Syringe, PistonFMF2Manufactureraccessdata.fda.gov
System, Irrigation, UrologicalLJH2Contract sterilizeraccessdata.fda.gov
System, Transport, AerobicJTW1Contract sterilizeraccessdata.fda.gov
Transport Systems, AnaerobicJTX1Contract sterilizeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 8, 2013K132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
October 18, 2011K112893CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
June 14, 2011K111217ADDITIVE CAPKPESubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
March 29, 2006K060074INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326FPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
October 19, 2000K003225SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVEFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
June 18, 1993K925126INTERLINK(TM) INJECTION SITEFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
April 21, 1993K924064INTERLINK UNIVERSAL VIAL ADAPTERLHISubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
April 20, 1993K921899INTERLINK SYSTEM - T-CONNECTOR EXTENSION SETFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
July 2, 1981K811078RADIATION STERILIZED ADMIN. SETFPASubstantially EquivalentTravenol Laboratories, S.A.accessdata.fda.gov

Compare with other makers

Updated October 8, 2013. 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.