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Data / Medical devices / Chile / Medline Chile SPA

Medline Chile SPA: FDA-registered device maker in Pudahuel Region Metropolitana, Chile, 23 510(k) clearances

Medline Chile SPA is registered with the FDA (registration 3027977504) in Pudahuel Region Metropolitana, Chile. It lists 38 device types. The FDA files 23 510(k) clearances under its listings, the newest dated March 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Medline Chile SPA
FDA registration number
3027977504
Address
Ave. Boulevard Poniente 1313 Bodenor Flexcenter, Pudahuel Region Metropolitana, Chile, 9031287
Owner or operator
Medline Chile SPA (10088604)
Roles
Exporter to the US
First device listed
August 28, 2023
Registered through
2026
Brand names listed
Disposable Bedding, Incontinence Garment, Medical Glove, Non-Surgical Gown, SensiCare Neoprene, SensiCare PI Micro

Devices it lists

DeviceProduct codeClassRoleSource
Airway, Oropharyngeal, AnesthesiologyCAE1Exporter to the USaccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Exporter to the USaccessdata.fda.gov
Bandage, CastITG1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Exporter to the USaccessdata.fda.gov
Catheter And Tip, SuctionJOL2Exporter to the USaccessdata.fda.gov
Catheter, IrrigationGBX1Exporter to the USaccessdata.fda.gov
Catheter, PeritonealGBW1Exporter to the USaccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Exporter to the USaccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Exporter to the USaccessdata.fda.gov
Drape, Surgical, ExemptPUI2Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Enteral Syringes With Enteral Specific ConnectorsPNR2Exporter to the USaccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Exporter to the USaccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Exporter to the USaccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Exporter to the USaccessdata.fda.gov
General Surgery TrayLRO2Exporter to the USaccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Marker, SkinFZZ1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Medical Glove, SpecialtyLZC1Exporter to the USaccessdata.fda.gov
Needle, Suturing, DisposableGAB1Exporter to the USaccessdata.fda.gov
Neurosurgical PaddieHBA2Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Razor, SurgicalLWK1Exporter to the USaccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Exporter to the USaccessdata.fda.gov
Stapler, SkinQQS1Exporter to the USaccessdata.fda.gov
Surgeon'S GlovesKGO1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Exporter to the USaccessdata.fda.gov
Tubing, NoninvasiveGAZ2Exporter to the USaccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Exporter to the USaccessdata.fda.gov
Wrap, SterilizationFRG2Exporter to the USaccessdata.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
March 26, 2024K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)FROSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
March 24, 2023K223236Medline Surgical Face Mask and Medline Procedural Face MaskFXXSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
October 6, 2022K220365Gemini Sterilization WrapFRGSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
April 6, 2020K193217SensiCare PI and SensiCare PI Micro Surgical GlovesKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
February 28, 2020K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 6, 2019K190502ENFit Oral / Enteral SyringePNRSubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
July 4, 2019K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)FYASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 24, 2019K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)FYASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
September 8, 2017K170415Medline Hemo-Force DVT Compression SleeveJOWSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 3, 2016K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-SterileLZASubstantially EquivalentKossan International Sdn Bhdaccessdata.fda.gov
September 26, 2014K140369MEDLINE NEURO SPONGEHBASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 25, 2011K110977VESOFLOWJOWSubstantially EquivalentCaremed Supply, Inc.accessdata.fda.gov
March 10, 2010K092409HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTERCAHSubstantially EquivalentIntersurgical, Inc.accessdata.fda.gov
December 14, 2006K062969MEDLINE STERILE DISPOSABLE SURGICAL GOWNSFYASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 14, 2006K061716PRESTIGE AMERITECH FACE MASKFXXSubstantially EquivalentPrestige Ameritechaccessdata.fda.gov
February 18, 2005K042683WELL LEAD ENDOTRACHEAL TUBEBTRSubstantially EquivalentWell Lead Medical Instrumentsaccessdata.fda.gov
July 7, 2003K030271VENTLAB BACTERIAL FILTER, MODEL BF100CAHSubstantially EquivalentVentlab Corp.accessdata.fda.gov
September 18, 2001K012842V*CARE MANUAL RESUSCITATORBTMSubstantially EquivalentVentlab Corp.accessdata.fda.gov
August 23, 1999K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXXSubstantially EquivalentMedline Industries, 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
January 26, 1993K925217MERIDIAN MEDICAL SYSTEMS BREATHING FILTERCAHSubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
February 22, 1979K790055TUBING, DYNACOR UNIVERSALGCXSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov

Compare with other makers

Updated March 26, 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.