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Data / Medical devices / Mexico / Tri-State De Mexico, S. De R.L. De C.V.

Tri-State De Mexico, S. De R.L. De C.V.: FDA-registered device maker in MEXICALI Baja California, Mexico, 32 510(k) clearances

Tri-State De Mexico, S. De R.L. De C.V. is registered with the FDA (registration 3004519921) in MEXICALI Baja California, Mexico. It lists 146 device types. The FDA files 32 510(k) clearances under its listings, the newest dated December 19, 2024. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Tri-State De Mexico, S. De R.L. De C.V.
FDA registration number
3004519921
FEI number
3005846326
Address
Calzada Presidente Venustiano Carranza #301 DESARROLLO INDUSTRIAL COLORADO, MEXICALI Baja California, Mexico, 21397
Owner or operator
Medline Industries, LP (1824619)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
August 21, 2001
Registered through
2027
Brand names listed
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass, Aplicare Alcohol Swabstick; Singles, Triples, BLADE, SCALPEL, CATHETER CARE TRAY, CONNECTOR, CATHETER, Catheter, hemodialysis, non-implanted, Centurion, Centurion Branded Kits and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Manufactureraccessdata.fda.gov
Angiography/Angioplasty KitOEQ2Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Applicator, VaginalHGD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Arterial Blood Sampling KitCBT1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bandage, CastITG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Blood And Urine Collection Kit (Excludes Hiv Testing)OIB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bone Marrow Biopsy TrayPXO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Breast Biopsy / Localization TrayPXP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Repackager or relabeleraccessdata.fda.gov
Cardiac Catheterization KitOES2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cardiovascular Procedure KitOEZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter Care TrayOHR2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter Introducer KitOFD2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Hemodialysis, Non-ImplantedMPB2Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Manufactureraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Contract manufactureraccessdata.fda.gov
Central Venous Catheter TrayOFF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Circumcision TrayOHG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
ClampHXD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Clamp, CircumcisionHFX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Clamp, UmbilicalHFW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Manufactureraccessdata.fda.gov
Connector, CatheterGCD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Ct Biopsy TrayOFG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Decontamination KitMAC1Manufactureraccessdata.fda.gov
Dental Hygiene KitNXZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dental Prophylaxis KitNYC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Manufactureraccessdata.fda.gov
Device, Occlusion, UmbilicalFOD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dress, SurgicalFYE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dressing Change TrayOXQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Ear Irrigation KitOGQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Ear, Nose, And Throat Surgical TrayOGR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Emergency Obstetrical KitOKU1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNManufacturer, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Tube IntroductionBWB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
General Purpose Dental TrayOFX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
General Purpose Instrument TrayPXV1Manufacturer, Repackager or relabeleraccessdata.fda.gov
General Surgery TrayLRO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
HemostatHRQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
I.V. Start KitLRS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Introducer, CatheterDYB2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Label Or Tag, SterileLYV1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Labor And Delivery KitMLS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laceration TrayPKD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Lens, Contact, Polymethylmethacrylate, DiagnosticHJK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Liver Biopsy KitPYA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Loop, WireJYQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Lumbar Puncture Tray (Adult & Pediatric)PWY2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Marker, SkinFZZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mirror, EntKAI1Repackager or relabeleraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Repackager or relabeleraccessdata.fda.gov
Neurosurgical Nerve LocatorPDQ2Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBURepackager or relabeleraccessdata.fda.gov
Pad, EyeHMP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pelvic Exam KitMLT2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plastic Surgery And Accessories KitFTN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Prep KitPXD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Protector, Skin PressureFMP1Repackager or relabeleraccessdata.fda.gov
Razor, SurgicalLWK1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Restraint, ProtectiveFMQ1Manufactureraccessdata.fda.gov
Retention Device, SutureKGS1Manufacturer, Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Retractor, FiberopticFDG1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Set, Administration, IntravascularFPA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Skin Prep TrayOJU1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Speculum, RectalFFQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stethoscope, ManualLDE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW3Contract manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyQRB3Contract manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Suture Removal KitMCZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Repackager or relabeleraccessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileNNZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Toothbrush, ManualEFW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tracheobronchial Suction Catheter KitOFR1Manufactureraccessdata.fda.gov
Tracheostomy And Nasal Suctioning KitLRQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tracheotomy Care KitNXA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Manufactureraccessdata.fda.gov
Tray, Start/Stop (Including Contents), DialysisFKG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Truss, UmbilicalEXM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tubing, Fluid DeliveryFPK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling CatheterFCN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Urine Collection Kit (Excludes Hiv Testing)OIE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Utensil, EatingILC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Vascular Access Port KitPXK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Venipuncture KitPXL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufactureraccessdata.fda.gov
Wound Dressing KitMCY2Manufacturer, Repackager or relabeleraccessdata.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
December 19, 2024K242370Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))GEISubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
May 24, 2022K213481Medline General Surgery TrayLROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
May 17, 2022K210548Medline Integrated Arterial CatheterDQXSubstantially EquivalentCenturion Medical Productsaccessdata.fda.gov
December 3, 2021K212258Medline Cardiovascular Procedure KitLROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
November 22, 2016K161408Compass Cast and MAPDRSSubstantially EquivalentCenturion Medical Products Corporationaccessdata.fda.gov
September 25, 2014K140088PHANTOM XL INSULATED DILATORSPDQSubstantially EquivalentTedan Surgical Innovations, LLCaccessdata.fda.gov
April 18, 2014K133624COMPASS CT, COMPASS CT PORTDRSSubstantially EquivalentMirador Biomedicalaccessdata.fda.gov
February 21, 2014K131426MEDLINE BIOPSY VALVEOCXSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
May 18, 2012K113565MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARINFOZSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
December 14, 2011K112203COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSISTDRSSubstantially EquivalentMirador Biomedical, Inc.accessdata.fda.gov
November 18, 2011K102833DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETSMPBSubstantially EquivalentFoshan Nanhai Bai HE Medical Technology Co., Ltd.accessdata.fda.gov
June 23, 2011K103562CENTURION PRESSURE INJECTABLE EXTENSION SETFPASubstantially EquivalentCenturion Medical Products Corporationaccessdata.fda.gov
January 20, 2011K103715COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSUREDRSSubstantially EquivalentMirador Biomedical, Inc.accessdata.fda.gov
December 17, 2010K100576HIGH PRESSURE SETS-400 PSIFPASubstantially EquivalentIcu Medical, Inc.accessdata.fda.gov
August 28, 2008K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESFMQSubstantially EquivalentTri-State Hospital Supply Corp.accessdata.fda.gov
May 2, 2008K080989UNIVERSAL VIAL ACCESS SPIKEFMFSubstantially EquivalentIcu Medical, Inc.accessdata.fda.gov
April 9, 2004K040052FINE SURGICAL CIRCUMCISION CLAMPHFXSubstantially EquivalentFine Surgical Instrument Corp.accessdata.fda.gov
August 24, 2001K012096DISPOSABLE VITRECTOMY LENSHJKSubstantially EquivalentOcular Instruments, Inc.accessdata.fda.gov
March 6, 2001K002689SWABSITE SWABBABLE VALVE, MODEL 245000FPASubstantially EquivalentQuest Medical, Inc.accessdata.fda.gov
November 26, 1996K962205STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USEKKXSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
June 13, 1994K936304ELECTROSURGICAL PENCILGEISubstantially EquivalentE & M Engineering, Inc.accessdata.fda.gov
March 7, 1994K931377SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENTFPASubstantially EquivalentMcgaw, Inc.accessdata.fda.gov
February 16, 1994K93133816 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)HGISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
April 1, 1991K910906CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETSFPKSubstantially EquivalentTri-State Hospital Supply Corp.accessdata.fda.gov
March 26, 1991K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEMIZISubstantially EquivalentNorth American Instrument Corp.accessdata.fda.gov
August 9, 1989K885179INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELDDYBSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
March 28, 1989K890897CENTURION CIRCLAMPHFXSubstantially EquivalentTri-State Hospital Supply Corp.accessdata.fda.gov
January 12, 1989K884408NAMIC DUAL BACKCHECK VALVEDTLSubstantially EquivalentNorth American Instrument Corp.accessdata.fda.gov
May 30, 1985K852140NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)FPASubstantially EquivalentNorth American Instrument Corp.accessdata.fda.gov
October 18, 1984K843726NAMIC ADB ANGIOGRAPHIC DUMP BAGDQOSubstantially EquivalentNorth American Instrument Corp.accessdata.fda.gov
October 27, 1983K833184APLICARE THREE ALCOHOL SWABSTICKSLKBSubstantially EquivalentAplicare, Inc.accessdata.fda.gov
January 23, 1979K782095STOPCOCKS, MANIFOLDSDTLSubstantially EquivalentNamicaccessdata.fda.gov

Compare with other makers

Updated December 19, 2024. 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.