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Data / Medical devices / Canada / Medline Canada

Medline Canada: FDA-registered device maker in Guelph Ontario, Canada, 20 510(k) clearances

Medline Canada is registered with the FDA (registration 3007289408) in Guelph Ontario, Canada. It lists 52 device types. The FDA files 20 510(k) clearances under its listings, the newest dated October 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 Medline Canada
FDA registration number
3007289408
Address
995 Southgate Road, Guelph Ontario, Canada, N1L 0B9
Owner or operator
Medline Industries, LP (1417592)
Roles
Exporter to the US
First device listed
December 29, 1977
Registered through
2026
Brand names listed
ACCU-SORB, AKTORmed, Accu-Wrap, Aquablation Therapy, BEDDING, BULKEE II, BULKEE LITE, Bandages and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, HygieneILS1Exporter to the USaccessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Exporter to the USaccessdata.fda.gov
Angiography/Angioplasty KitOEQ2Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Basin, EmesisFNY1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Exporter to the USaccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the USaccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Exporter to the USaccessdata.fda.gov
Cardiovascular Procedure KitOEZ2Exporter to the USaccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Exporter to the USaccessdata.fda.gov
Chair, With CastersINM1Exporter to the USaccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Exporter to the USaccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Exporter to the USaccessdata.fda.gov
Container, Specimen, SterileFMH1Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter 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, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Exporter to the USaccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Exporter to the USaccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Exporter to the USaccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
General Surgery TrayLRO2Exporter to the USaccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Exporter to the USaccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Exporter to the USaccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Exporter to the USaccessdata.fda.gov
Joint, Ankle, External BraceITW1Exporter to the USaccessdata.fda.gov
Laparoscopy KitFDE2Exporter to the USaccessdata.fda.gov
Medical Glove, SpecialtyLZC1Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Orthopedic TrayOJH1Exporter to the USaccessdata.fda.gov
Orthosis, CervicalIQK1Exporter to the USaccessdata.fda.gov
Pessary, VaginalHHW2Exporter to the USaccessdata.fda.gov
Plastic Surgery And Accessories KitFTN1Exporter to the USaccessdata.fda.gov
Pump, Infusion, EnteralLZH2Exporter to the USaccessdata.fda.gov
RetractorGAD1Exporter to the USaccessdata.fda.gov
Scissors, General, SurgicalLRW1Exporter to the USaccessdata.fda.gov
Snare, TonsilKBZ1Exporter to the USaccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Exporter to the USaccessdata.fda.gov
Splint, Hand, And ComponentsILH1Exporter to the USaccessdata.fda.gov
Surgeon'S GlovesKGO1Exporter to the USaccessdata.fda.gov
System, X-Ray, AngiographicIZI2Exporter to the USaccessdata.fda.gov
Tracheobronchial Suction Catheter KitOFR1Exporter to the USaccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Exporter to the USaccessdata.fda.gov
Wheelchair, MechanicalIOR1Exporter 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
October 3, 2023K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
October 6, 2022K220365Gemini Sterilization WrapFRGSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
December 19, 2020K202668Signature Latex and Signature Latex Micro, 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
April 6, 2020K193217SensiCare PI and SensiCare PI Micro Surgical GlovesKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 1, 2020K192988Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for UseKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
March 6, 2020K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGOSubstantially 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
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 5, 2016K151503NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBEPIFSubstantially EquivalentGbuk Enteral Limitedaccessdata.fda.gov
July 22, 2010K092981PANPAC VAGINAL PESSARYHHWSubstantially EquivalentPanpac Medical Corporationaccessdata.fda.gov
February 18, 2005K042683WELL LEAD ENDOTRACHEAL TUBEBTRSubstantially EquivalentWell Lead Medical Instrumentsaccessdata.fda.gov
December 1, 2004K033732MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450FROSubstantially EquivalentMedtrade Products , Ltd.accessdata.fda.gov
March 15, 1999K990463MEDLINE EXCEL WHEELCHAIRSIORSubstantially EquivalentMedlineaccessdata.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
January 26, 1993K925217MERIDIAN MEDICAL SYSTEMS BREATHING FILTERCAHSubstantially EquivalentMerit Medical Systems, Inc.accessdata.fda.gov
March 26, 1991K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEMIZISubstantially EquivalentNorth American Instrument Corp.accessdata.fda.gov
September 12, 1989K891575COMPAT ENTERAL FEED PUMP 199235 & 199240LZHSubstantially EquivalentSandoz Nutritionaccessdata.fda.gov
February 5, 1988K873955NAMIC ANGIOGRAPHIC SYRINGEDXTSubstantially EquivalentNorth American Instrument Corp.accessdata.fda.gov
August 24, 1982K822100HIGH PRESSURE CONTRAST INJECTION LINEDQOSubstantially EquivalentNamicaccessdata.fda.gov
January 23, 1979K782095STOPCOCKS, MANIFOLDSDTLSubstantially EquivalentNamicaccessdata.fda.gov

Compare with other makers

Updated October 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.