Data / Medical devices / Canada / Numed Canada, Inc.
Numed Canada, Inc.: FDA-registered device maker in CORNWALL Ontario, Canada, 20 510(k) clearances
Numed Canada, Inc. is registered with the FDA (registration 9618000) in CORNWALL Ontario, Canada. It lists 7 device types. The FDA files 20 510(k) clearances under its listings, the newest dated July 19, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9618000
- FEI number
- 3003245778
- Address
- 45 Second Street West, CORNWALL Ontario, Canada, K6J 1G3
- Owner or operator
- NUMED CANADA, INC. (9044991)
- Roles
- Manufacturer
- First device listed
- October 19, 2007
- Registered through
- 2027
- Brand names listed
- COEfficient, Ghost, Ghost II, Mini Ghost, Mullins-X, NuCLEUS, NuCLEUS-X, PTS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon Aortic Valvuloplasty | OZT | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Septostomy | DXF | 2 | Manufacturer | accessdata.fda.gov |
| Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | OMZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 19, 2021 | K211910 | Z-6 Atrioseptostomy Catheter | DXF | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| October 4, 2012 | K122012 | Z-MED Z-MED II | OZT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| August 31, 2012 | K121859 | TYSHAK NUCLEUS | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| June 11, 2012 | DEN080015 | NUCLEUS-X PTV CATHETER | OZT | Unknown | NuMED, Inc. | accessdata.fda.gov |
| December 9, 2010 | K102473 | MULLINS-X PTV CATHETER | OMZ | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| July 10, 2008 | K081680 | NUCLEUS-X, MODEL 230X | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| July 28, 2005 | K051343 | MINI GHOST PTA CATHETER, MODEL 507 | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| June 10, 2004 | K041306 | NUMED PTS X SIZING BALLOON CATHETER | MJN | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| May 6, 2004 | K041093 | NUMED MULLINS X PTA CATHETER | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| September 25, 2003 | K032591 | NUMED TYSHAK MINI PEDIATRIC PTV CATHETER | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| May 21, 2003 | K030589 | MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| September 13, 2002 | K022722 | PTA AND PTV | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| January 16, 2002 | K014124 | NUMED COEFFICIENT PTV CATHETERS | OMZ | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| May 2, 2001 | K003320 | PTA-OS SIZING BALLOON, MODEL 360 | MJN | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| January 11, 2001 | K003972 | NUMED GHOST II PTA CATHETERS | LIT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| December 1, 2000 | K003276 | TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 | LIT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| November 1, 2000 | K003052 | NUMED TYSHAK II AND Z-MED II PTV CATHETERS | LIT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| September 27, 2000 | K991977 | TYSHAK, MODEL 102 AND Z-MED, MODEL 302 | LIT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| April 2, 1996 | K960070 | NUMED ATRIOSEPTOSTOMY CATHETER | DQO | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| December 21, 1993 | K931009 | TYSHAK PERIPHERAL BALLOON DILATION CATHETER | LIT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous
- All makers of Balloon Aortic Valvuloplasty
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter, Septostomy
Updated July 19, 2021. 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.