Data / Medical devices / Canada / Cardinal Health Canada Inc.
Cardinal Health Canada Inc.: FDA-registered device maker in Vaughan Ontario, Canada, 7 510(k) clearances
Cardinal Health Canada Inc. is registered with the FDA (registration 3009176340) in Vaughan Ontario, Canada. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 9, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009176340
- Address
- 1000 Tesma Way, Vaughan Ontario, Canada, L4K 5R8
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Exporter to the US
- First device listed
- February 13, 2006
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Sterile | FMH | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Exporter to the US | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Exporter to the US | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Exporter to the US | accessdata.fda.gov |
| Tube, Tissue Culture | KJG | 1 | Exporter to the US | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 9, 2017 | K170762 | Cardinal Health Non-Reinforced Surgical Gown | FYA | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| April 20, 2015 | K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home | OMP | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| July 15, 2004 | K040649 | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE | JOW | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| October 11, 2002 | K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| October 2, 2002 | K023167 | BREATHABLE SURGICAL GOWN | FYA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| December 15, 1997 | K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | FRO | Substantially Equivalent for Some Indications | Kendall Healthcare Products Co. Div.Of Tyco Health | accessdata.fda.gov |
| February 4, 1986 | K854547 | MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE | FMI | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Tissue Culture
- All makers of Sleeve, Limb, Compressible
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Gown, Surgical
- All makers of Tourniquet, Nonpneumatic
- All makers of Polymer Patient Examination Glove
Updated June 9, 2017. 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.