Data / Medical devices / Canada / Canadian Hospital Specialties Ltd
Canadian Hospital Specialties Ltd: FDA-registered device maker in Burlington Ontario, Canada, 9 510(k) clearances
Canadian Hospital Specialties Ltd is registered with the FDA (registration 3003627840) in Burlington Ontario, Canada. It lists 17 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 3, 2014. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003627840
- Address
- 1213 International Blvd., Burlington Ontario, Canada, L7L 6W1
- Owner or operator
- Canadian Hospital Specialties Ltd. (10044194)
- Roles
- Exporter to the US, Specification developer
- First device listed
- May 10, 2013
- Registered through
- 2026
- Brand names listed
- Asept, Safely Drain Line Adapter, Disposable CT/MR Syringes for Nemoto Injectors, MED-RX, MED-RX Cysto/Bladder Irrigation Set, MED-RX EXTENSION SET WITH T-CONNECTOR, MED-RX EXTENSION SETS, MED-RX Insufflation Filter Set, MED-RX ORAL/ENTERAL SYRINGE and more
Devices it lists
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 3, 2014 | K131183 | MED-RX ORAL/ENTERAL SYRINGE | KNT | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| June 28, 2012 | K120375 | MED-RX PATIENT DELIVERY SET | FPA | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| December 23, 2011 | K112799 | MED-RX EXTENSION SET WITH T-CONNECTOR | FPA | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| December 13, 2010 | K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES | FPD | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| November 8, 2010 | K102073 | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS | FPA | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| May 2, 2008 | K072696 | ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 | DXT | Substantially Equivalent | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | accessdata.fda.gov |
| November 28, 2001 | K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 | LJH | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| June 14, 2000 | K001068 | NBS CONNECTING TUBE SET | HIF | Substantially Equivalent | Nbs Products CO | accessdata.fda.gov |
| August 25, 1999 | K990777 | MED-RX EXTENSION SETS | FPA | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
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Updated June 3, 2014. 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.