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Data / Medical devices / United States / MEDLINE INDUSTRIES, LP - Laredo

MEDLINE INDUSTRIES, LP - Laredo: FDA-registered device maker in Laredo, TX, United States, 10 510(k) clearances

MEDLINE INDUSTRIES, LP - Laredo is registered with the FDA (registration 3005595283) in Laredo, TX, United States. It lists 96 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 2, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3005595283
Address
12001 General Milton Drive, Laredo, TX, United States, 78045
Owner or operator
Medline Industries, LP (1417592)
Roles
Manufacturer, Manufacturer for export, Repackager or relabeler, Reprocessor
First device listed
May 15, 1979
Registered through
2026
Brand names listed
137075-Surgical SetUp CSTM, 140928-Suture Removal Kit CSTM, 147572-Sterile Circumcision Tray CSTM, 170019-Convenience Trays & Kits CSTM, 171415-O.R. KIT CSTM, 321236-Sterile Biospy CSTM, 946240-Skin Prep CSTM, ACCU-SORB and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Repackager or relabeleraccessdata.fda.gov
Angiography/Angioplasty KitOEQ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Repackager or relabeleraccessdata.fda.gov
Arterial Blood Sampling KitCBT1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Arthrogram TrayOII2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Manufactureraccessdata.fda.gov
Basin, EmesisFNY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Manufactureraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Blood And Urine Collection Kit (Excludes Hiv Testing)OIB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Breast Pump KitOHH2Manufactureraccessdata.fda.gov
Cardiac Catheterization KitOES2Manufactureraccessdata.fda.gov
Cardiovascular Procedure KitOEZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter Care TrayOHR2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter Introducer KitOFD2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Repackager or relabeleraccessdata.fda.gov
Central Venous Catheter TrayOFF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cesarean Section TrayOHM2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chest Drainage KitPAD2Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Manufactureraccessdata.fda.gov
Circumcision TrayOHG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
ClampHXD1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Clamp, CircumcisionHFX2Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Container, Specimen, SterileFMH1Repackager or relabeleraccessdata.fda.gov
Ct Biopsy TrayOFG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Decontamination KitMAC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Depressor, OrbitalHNX1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Device, Percutaneous, BiopsyMJG1Manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Repackager or relabeleraccessdata.fda.gov
Ear, Nose, And Throat Surgical TrayOGR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Endoscope Introducer KitNWU2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Epidural Anesthesia KitOGE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Eye TrayOJK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
First Aid Kit Without DrugOHO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Foley Catheter Kit (Excludes Hiv Testing)PPB2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Forceps, OphthalmicHNR1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Repackager or relabeleraccessdata.fda.gov
General Purpose Dental TrayOFX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
General Surgery TrayLRO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gown, SurgicalFYA2Repackager or relabeleraccessdata.fda.gov
Gynecological Laparoscopic KitOHD2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Reprocessoraccessdata.fda.gov
HemostatHRQ1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Hysterectomy KitOJF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
I.V. Start KitLRS2Manufactureraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Intravenous Extension Tubing SetOJA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Manufacturer, Manufacturer for export, Repackager or relabeleraccessdata.fda.gov
Label Or Tag, SterileLYV1Manufactureraccessdata.fda.gov
Labor And Delivery KitMLS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laceration TrayPKD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Laparoscopy KitFDE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Repackager or relabeleraccessdata.fda.gov
Nerve Block TrayOGJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Neurological TrayOJG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Obstetrical KitOKV2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthopedic TrayOJH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Patient Personal Hygiene KitNSB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plastic Surgery And Accessories KitFTN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Retractor, All TypesEIG1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Scalpel, One-PieceGDX1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Scissors, OphthalmicHNF1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Skin Prep TrayOJU1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Specula, OphthalmicHNC1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Speculum, EntEPY1Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Spinal Epidural Anesthesia KitOFT2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Surgeon'S GlovesKGO1Repackager or relabeleraccessdata.fda.gov
Suture Removal KitMCZ1Manufactureraccessdata.fda.gov
Tracheobronchial Suction Catheter KitOFR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tracheostomy Cleaning TrayOGV2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tracheotomy Care KitNXA2Manufactureraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Repackager or relabeleraccessdata.fda.gov
Tray, Biopsy, Without Biopsy InstrumentsFCH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Manufactureraccessdata.fda.gov
Tray, Surgical, EntMMO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling CatheterFCN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Wound Dressing KitMCY2Manufactureraccessdata.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 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
May 8, 2013K123095MEDLINE BLOOD PRESSURE TRANSDUCERDRSSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 17, 2012K120008MEDLINE HIGH PRESSURE INJECTION TUBINGDQOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 3, 2012K120069MEDLINE STOPCOCK AND MANIFOLDDTLSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 9, 2004K040052FINE SURGICAL CIRCUMCISION CLAMPHFXSubstantially EquivalentFine Surgical Instrument Corp.accessdata.fda.gov
March 16, 2004K040503ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOURKGOSubstantially EquivalentWrp Asia Pacific Sdn. Bhd.accessdata.fda.gov
August 14, 1997K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPSGEISubstantially EquivalentTecno Instruments (Usa), Inc.accessdata.fda.gov
February 25, 1997K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKXSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
September 16, 1996K962826MEDLINE RADIOLOGY-DIAGNOSTIC KITSLROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
February 22, 1994K932654ELECTROSURGIAL INSTRUMENTSGEISubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
July 21, 202290689Class IIOngoingMedline CHEST TUBE REORDER NO: DYNJ36762ADue to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kitaccessdata.fda.gov

Compare with other makers

Updated November 2, 2015. 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.