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Data / Medical devices / Costa Rica / Cardinal Health Costa Rica, S.A.

Cardinal Health Costa Rica, S.A.: FDA-registered device maker in -- Alajuela, Costa Rica, 26 510(k) clearances

Cardinal Health Costa Rica, S.A. is registered with the FDA (registration 3009211636) in -- Alajuela, Costa Rica. It lists 27 device types. The FDA files 26 510(k) clearances under its listings, the newest dated April 3, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Cardinal Health Costa Rica, S.A.
FDA registration number
3009211636
Address
Edificio B20 Calle #2 Zona Franca Coyol, -- Alajuela, Costa Rica, --
Owner or operator
Cardinal Health 200, LLC (9028292)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
August 4, 1999
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Exporter to the USaccessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF2Manufactureraccessdata.fda.gov
Catheter, Hemodialysis, ImplantedMSD2Contract manufactureraccessdata.fda.gov
Catheter, Hemodialysis, Implanted, CoatedNYU2Contract manufactureraccessdata.fda.gov
Catheter, Hemodialysis, Non-ImplantedMPB2Contract manufactureraccessdata.fda.gov
Catheter, Hemodialysis, Triple Lumen, Non-ImplantedNIE2Contract manufactureraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS2Manufactureraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, Peritoneal Dialysis, Single UseFKO2Contract manufactureraccessdata.fda.gov
Catheter, Peritoneal, Long-Term IndwellingFJS2Contract manufactureraccessdata.fda.gov
Catheter, Umbilical ArteryFOS2Manufactureraccessdata.fda.gov
Dialysis Administration KitPEV2Contract manufactureraccessdata.fda.gov
Dilator, Vessel, For Percutaneous CatheterizationDRE2Contract manufactureraccessdata.fda.gov
Introducer, CatheterDYB2Contract manufacturer, Manufactureraccessdata.fda.gov
Kit, Repair, Catheter, HemodialysisNFK2Contract manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Exporter to the USaccessdata.fda.gov
Peripheral Catheter Insertion KitOWL2Manufactureraccessdata.fda.gov
Pump, InfusionFRN2Manufactureraccessdata.fda.gov
Pump, Infusion, EnteralLZH2Manufactureraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Manufactureraccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Contract manufacturer, Manufactureraccessdata.fda.gov
Stopcock, I.V. SetFMG2Repackager or relabeleraccessdata.fda.gov
Stylet, CatheterDRB2Contract manufactureraccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Manufactureraccessdata.fda.gov
Wire, Guide, CatheterDQX2Contract manufactureraccessdata.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
April 3, 2023K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing AssemblyJOWSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
December 20, 2022K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™LZHSubstantially EquivalentCardinal Health, LLCaccessdata.fda.gov
July 6, 2016K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalLZHSubstantially EquivalentCovidienaccessdata.fda.gov
November 5, 2013K132567ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMENLJSSubstantially EquivalentCovidienaccessdata.fda.gov
April 17, 2013K130725MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.FOSSubstantially EquivalentCovidien Lp, Formerly Registered AS Kendallaccessdata.fda.gov
February 14, 2013K130049MONOJECT 12ML SYRINGEFMFSubstantially EquivalentNipro Medical Corporationaccessdata.fda.gov
May 4, 2010K100306KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVESJOWSubstantially EquivalentCovidienaccessdata.fda.gov
October 13, 2005K051805KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGEJOWSubstantially EquivalentTyco Healthcare/Kendallaccessdata.fda.gov
July 15, 2004K040649KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVEJOWSubstantially EquivalentTyco Healthcareaccessdata.fda.gov
June 28, 2004K040511SCD EXPRESS PORTABLE COMPRESSION SYSTEMJOWSubstantially EquivalentTyco Healthcare/Kendallaccessdata.fda.gov
May 5, 2004K040196KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETSLZHSubstantially EquivalentTyco Healthcare/Kendallaccessdata.fda.gov
September 29, 1995K951738ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETERFOSSubstantially EquivalentSherwood Medical Co.accessdata.fda.gov
September 28, 1995K951737ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAYFOSSubstantially EquivalentSherwood Medical Co.accessdata.fda.gov
March 7, 1995K945964KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETSLZHSubstantially Equivalent - Subject to Tracking Reg.Sherwood Medical Co.accessdata.fda.gov
September 30, 1994K941814ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETERFOSSubstantially EquivalentSherwood Medical Co.accessdata.fda.gov
August 25, 1994K942564ARGYLE NEO-SERTFOSUnknownSherwood Medical Co.accessdata.fda.gov
October 6, 1992K920908OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1DYBSubstantially EquivalentTeleflexmedical, Inc.accessdata.fda.gov
June 12, 1985K851539CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLOKNTSubstantially EquivalentChesebrough-Pond'S U.S.A. Co.accessdata.fda.gov
October 18, 1984K843444ARGYLE SILICONE LEFT VENTRICULAR ANDDWFSubstantially EquivalentSherwood Medical Co.accessdata.fda.gov
August 31, 1982K822317ARGYLE CAROTID ARTERY LOOP SHUNTDWFSubstantially EquivalentSherwood Medical Co.accessdata.fda.gov
July 30, 1982K821445ARGYLE FERGUSON LEFT ATRIAL VENT CATHDWFSubstantially EquivalentSherwood Medical Co.accessdata.fda.gov
March 24, 1981K810530PERI-PATCH GLUE MOLDKGZSubstantially EquivalentQuinton, Inc.accessdata.fda.gov
August 13, 1980K801725KANGAROO ENTERAL FEEDING PUMPFRNSubstantially EquivalentChesebrough-Pond'S U.S.A. Co.accessdata.fda.gov
January 16, 1980K7921253&4 WAY PLASTIC STOPCOCKS, NONSTERILEFMGSubstantially EquivalentTronomed, Inc.accessdata.fda.gov
September 20, 1978K781357T.E.D. SEQUENTIAL COMPRESSION SLEEVESJOWSubstantially EquivalentKendall Research Centeraccessdata.fda.gov
January 26, 1977K760966CATHETER, UMBILICAL ARTERYFOSSubstantially EquivalentSherwood Medical Industriesaccessdata.fda.gov

Compare with other makers

Updated April 3, 2023. 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.