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Data / Medical devices / Mexico / Medline Industries, LP - Mexicali (MXC)

Medline Industries, LP - Mexicali (MXC): FDA-registered device maker in Mexicali Baja California, Mexico, 13 510(k) clearances

Medline Industries, LP - Mexicali (MXC) is registered with the FDA (registration 3015173212) in Mexicali Baja California, Mexico. It lists 200 device types. The FDA files 13 510(k) clearances under its listings, the newest dated November 18, 2020. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Medline Industries, LP - Mexicali (MXC)
FDA registration number
3015173212
Address
Calle Circuito del Desierto # 71 Parque Industrial del Desierto, Mexicali Baja California, Mexico, 21383
Owner or operator
Medline Industries, LP (1417592)
Roles
Complaint file establishment, Contract sterilizer, Manufacturer, Repackager or relabeler
First device listed
December 29, 1977
Registered through
2026
Brand names listed
"Salt Airway S.A.L.T.", 137075-Surgical SetUp CSTM, 140928-Suture Removal Kit CSTM, 145666-Dressing Change CSTM, 147572-Sterile Circumcision Tray CSTM, 170019-Convenience Trays & Kits CSTM, 321236-Sterile Biospy CSTM, 946240-Skin Prep CSTM and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Contract sterilizeraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Contract sterilizeraccessdata.fda.gov
Adaptor, DressingILD1Contract sterilizeraccessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Contract sterilizeraccessdata.fda.gov
Airway, NasopharyngealBTQ1Contract sterilizeraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Contract sterilizeraccessdata.fda.gov
Anesthesia KitOFQ2Contract sterilizeraccessdata.fda.gov
Angiography/Angioplasty KitOEQ2Contract sterilizeraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Contract sterilizeraccessdata.fda.gov
Applicator, VaginalHGD1Contract sterilizeraccessdata.fda.gov
Arterial Blood Sampling KitCBT1Contract sterilizeraccessdata.fda.gov
Arthrogram TrayOII2Contract sterilizeraccessdata.fda.gov
ArthroscopeHRX2Contract sterilizeraccessdata.fda.gov
Aspiration TrayOJT1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Contract sterilizeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Contract sterilizer, Manufactureraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Blood And Urine Collection Kit (Excludes Hiv Testing)OIB1Contract sterilizer, Manufactureraccessdata.fda.gov
Body Fluid Clean Up KitOKG2Manufactureraccessdata.fda.gov
Breast Biopsy / Localization TrayPXP1Contract sterilizeraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Repackager or relabeleraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Contract sterilizeraccessdata.fda.gov
Burn Kit Without DrugOJJ1Manufactureraccessdata.fda.gov
Cardiac Catheterization KitOES2Contract sterilizer, Manufactureraccessdata.fda.gov
Cardiovascular Procedure KitOEZ2Contract sterilizer, Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Contract sterilizeraccessdata.fda.gov
Catheter Care TrayOHR2Manufactureraccessdata.fda.gov
Catheter Introducer KitOFD2Contract sterilizeraccessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF2Contract sterilizeraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Contract sterilizeraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Contract sterilizeraccessdata.fda.gov
Catheter, IrrigationGBX1Complaint file establishment, Contract sterilizeraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Contract sterilizeraccessdata.fda.gov
Catheter, UrologicalKOD2Contract sterilizeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Contract sterilizeraccessdata.fda.gov
Cement ObturatorLZN2Contract sterilizeraccessdata.fda.gov
Central Venous Catheter Dressing Change KitPEZ2Contract sterilizeraccessdata.fda.gov
Central Venous Catheter TrayOFF2Contract sterilizer, Manufactureraccessdata.fda.gov
Cesarean Section TrayOHM2Manufactureraccessdata.fda.gov
Chest Drainage KitPAD2Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Manufactureraccessdata.fda.gov
Circumcision TrayOHG2Contract sterilizer, Manufactureraccessdata.fda.gov
ClampHXD1Contract sterilizeraccessdata.fda.gov
Clamp, CircumcisionHFX2Contract sterilizeraccessdata.fda.gov
Clamp, UmbilicalHFW2Contract sterilizeraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Repackager or relabeleraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Contract sterilizeraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Contract sterilizeraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Contract sterilizeraccessdata.fda.gov
Container, Specimen, SterileFMH1Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cover, Barrier, ProtectiveMMP2Contract sterilizeraccessdata.fda.gov
Cover, LimbIPM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Ct Biopsy TrayOFG2Contract sterilizer, Manufactureraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Contract sterilizeraccessdata.fda.gov
CuretteHTF1Contract sterilizeraccessdata.fda.gov
Custom Anesthesia TrayOGD2Contract sterilizeraccessdata.fda.gov
Decontamination KitMAC1Contract sterilizeraccessdata.fda.gov
Dental Hygiene KitNXZ1Contract sterilizeraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Contract sterilizeraccessdata.fda.gov
Device, Percutaneous, BiopsyMJG1Contract sterilizeraccessdata.fda.gov
Dialysis Administration KitPEV2Manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Contract sterilizer, Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dress, SurgicalFYE1Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dressing Change TrayOXQ1Contract sterilizer, Manufactureraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Contract sterilizeraccessdata.fda.gov
Ear, Nose, And Throat Surgical TrayOGR1Contract sterilizer, Manufactureraccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Contract sterilizeraccessdata.fda.gov
Electrode, Pacemaker, TemporaryLDF2Contract sterilizeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract sterilizer, Manufactureraccessdata.fda.gov
Endoscope Introducer KitNWU2Manufactureraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Contract sterilizeraccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Contract sterilizeraccessdata.fda.gov
Epidural Anesthesia KitOGE2Contract sterilizer, Manufactureraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Contract sterilizeraccessdata.fda.gov
Eye TrayOJK2Manufactureraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Contract sterilizeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract sterilizeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNContract sterilizeraccessdata.fda.gov
Foley Catheter Kit (Excludes Hiv Testing)PPB2Manufactureraccessdata.fda.gov
ForcepsHTD1Contract sterilizeraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Contract sterilizeraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Contract sterilizeraccessdata.fda.gov
Forceps, Tube IntroductionBWB1Contract sterilizeraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Contract sterilizeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Contract sterilizeraccessdata.fda.gov
General Purpose Dental TrayOFX1Contract sterilizer, Manufactureraccessdata.fda.gov
General Surgery TrayLRO2Contract sterilizer, Manufactureraccessdata.fda.gov
Generator, Lesion, RadiofrequencyGXD2Contract sterilizeraccessdata.fda.gov
Gown, SurgicalFYA2Repackager or relabeleraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Contract sterilizeraccessdata.fda.gov
Gynecological Laparoscopic KitOHD2Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Contract sterilizeraccessdata.fda.gov
HemostatHRQ1Contract sterilizeraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Contract sterilizeraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Contract sterilizeraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Contract sterilizeraccessdata.fda.gov
Hysterectomy KitOJF2Manufactureraccessdata.fda.gov
I.V. Start KitLRS2Contract sterilizer, Manufactureraccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Contract sterilizeraccessdata.fda.gov
Instrument, BiopsyKNW2Contract sterilizeraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Contract sterilizeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract sterilizer, Manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Contract sterilizeraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUContract sterilizeraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Contract sterilizeraccessdata.fda.gov
Introducer, CatheterDYB2Contract sterilizeraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Label Or Tag, SterileLYV1Contract sterilizer, Repackager or relabeleraccessdata.fda.gov
Labor And Delivery KitMLS2Contract sterilizer, Manufactureraccessdata.fda.gov
Laceration TrayPKD1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract sterilizer, Manufactureraccessdata.fda.gov
Laparoscopy KitFDE2Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Contract sterilizeraccessdata.fda.gov
Lavage, JetFQH2Manufactureraccessdata.fda.gov
Marker, SkinFZZ1Contract sterilizeraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Contract sterilizer, Repackager or relabeleraccessdata.fda.gov
Mirror, EntKAI1Contract sterilizeraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Contract sterilizeraccessdata.fda.gov
Monitor, Line IsolationDRI1Contract sterilizeraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Contract sterilizeraccessdata.fda.gov
Needle, CatheterGCB1Contract sterilizeraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Contract sterilizeraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Contract sterilizeraccessdata.fda.gov
Nerve Block TrayOGJ2Contract sterilizeraccessdata.fda.gov
Neurological TrayOJG1Manufactureraccessdata.fda.gov
Obstetrical KitOKV2Manufactureraccessdata.fda.gov
Orthopedic TrayOJH1Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeleraccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBUContract sterilizer, Manufactureraccessdata.fda.gov
Pad, EyeHMP1Contract sterilizeraccessdata.fda.gov
Patient Personal Hygiene KitNSB1Manufactureraccessdata.fda.gov
Pelvic Exam KitMLT2Contract sterilizer, Manufactureraccessdata.fda.gov
Plastic Surgery And Accessories KitFTN1Contract sterilizer, Manufactureraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Probe, Radiofrequency LesionGXI2Contract sterilizeraccessdata.fda.gov
Razor, SurgicalLWK1Contract sterilizeraccessdata.fda.gov
Restraint, ProtectiveFMQ1Contract sterilizeraccessdata.fda.gov
Retention Device, SutureKGS1Contract sterilizeraccessdata.fda.gov
RetractorGAD1Contract sterilizeraccessdata.fda.gov
Scalpel, One-PieceGDX1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Contract sterilizeraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Contract sterilizeraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract sterilizeraccessdata.fda.gov
Sealant, MicrobialNZP2Contract sterilizeraccessdata.fda.gov
Set, Administration, IntravascularFPA2Contract sterilizer, Manufactureraccessdata.fda.gov
Single Use Instrument TrayOJV1Contract sterilizeraccessdata.fda.gov
Skin Prep TrayOJU1Contract sterilizer, Manufactureraccessdata.fda.gov
Sound, UterineHHM1Contract sterilizeraccessdata.fda.gov
Speculum, EntEPY1Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Speculum, RectalFFQ1Contract sterilizeraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Contract sterilizeraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Repackager or relabeleraccessdata.fda.gov
Spinal Epidural Anesthesia KitOFT2Contract sterilizer, Manufactureraccessdata.fda.gov
Staple, Fixation, BoneJDR2Contract sterilizeraccessdata.fda.gov
Staple, Removable (Skin)GDT1Contract sterilizer, Repackager or relabeleraccessdata.fda.gov
Stapler, SurgicalGAG2Contract sterilizeraccessdata.fda.gov
Stethoscope, ManualLDE1Contract sterilizeraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW3Contract sterilizeraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyQRB3Contract sterilizeraccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Repackager or relabeleraccessdata.fda.gov
Stopcock, I.V. SetFMG2Contract sterilizeraccessdata.fda.gov
Surgeon'S GlovesKGO1Contract sterilizer, Repackager or relabeleraccessdata.fda.gov
Suture KitOVN2Contract sterilizer, Manufactureraccessdata.fda.gov
Suture Removal KitMCZ1Contract sterilizer, Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Contract sterilizeraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Contract sterilizeraccessdata.fda.gov
System, Irrigation, UrologicalLJH2Contract sterilizeraccessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileNNZ1Contract sterilizeraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Contract sterilizeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Contract sterilizeraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Contract sterilizeraccessdata.fda.gov
Toothbrush, ManualEFW1Contract sterilizeraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Contract sterilizer, Repackager or relabeleraccessdata.fda.gov
Tracheobronchial Suction Catheter KitOFR1Contract sterilizer, Manufactureraccessdata.fda.gov
Tracheostomy And Nasal Suctioning KitLRQ1Contract sterilizeraccessdata.fda.gov
Tracheotomy Care KitNXA2Contract sterilizer, Manufactureraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Contract sterilizeraccessdata.fda.gov
Transducer, Pressure, Catheter TipDXO2Contract sterilizeraccessdata.fda.gov
Tray, Biopsy, Without Biopsy InstrumentsFCH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)FCM2Manufactureraccessdata.fda.gov
Tray, Start/Stop (Including Contents), DialysisFKG1Contract sterilizeraccessdata.fda.gov
Tray, SurgicalLRP1Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, EntMMO1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Contract sterilizeraccessdata.fda.gov
Tube, Ear SuctionJZF1Contract sterilizeraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Contract sterilizeraccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Manufactureraccessdata.fda.gov
Tubing, Fluid DeliveryFPK2Contract sterilizeraccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Contract sterilizeraccessdata.fda.gov
UrinalFNP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Wire, Guide, CatheterDQX2Contract sterilizeraccessdata.fda.gov
Wound Dressing KitMCY2Contract sterilizer, 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
November 18, 2020K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable ProteinKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
December 20, 2016K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)KGOSubstantially EquivalentHartalega Sdb. Bhd.accessdata.fda.gov
November 2, 2015K142941Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.KGOSubstantially EquivalentPt. Medisafe Technologiesaccessdata.fda.gov
March 23, 2012K120743SPECULUM, VAGINAL, NONMETALHIBSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
March 1, 2012K112769CURAD COMPRESSION HOSIERYDWLSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
May 15, 2009K090066POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVEKGOSubstantially EquivalentWear Safe (Malaysia) Sdn. Bhd.accessdata.fda.gov
August 3, 2005K051378POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)LZASubstantially EquivalentMedlineaccessdata.fda.gov
March 8, 2005K043017PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNSFYASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
May 3, 2002K020393MASTER & FRANK SURGICAL DRAPES (STERILE)KKXSubstantially EquivalentMaster & Frank Enterprses Co., Ltd.accessdata.fda.gov
September 7, 2000K001872I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411FPASubstantially EquivalentCodan US Corp.accessdata.fda.gov
February 25, 1997K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKXSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 30, 1996K960858GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATORJKASubstantially EquivalentGreiner America, Inc.accessdata.fda.gov
February 22, 1994K932654ELECTROSURGIAL INSTRUMENTSGEISubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov

Compare with other makers

Updated November 18, 2020. 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.