Company
MDS Canada Inc. DBA MDS Nordion
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2009 | MDS Canada Inc. DBA MDS Nordion TheraSphere Administration Set (Part Number K125914-034).
TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellul Terminated |
NAW | None listed |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron Elite 100 Cobalt Radiotherapy Terminated |
IWB | K983917 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron Elite 80 Cobalt Radiotherapy Terminated |
IWB | K983917 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron Phoenix Cobalt Radiotherapy Terminated |
IWB | K863180 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron 1000E Cobalt Radiotherapy Terminated |
IWB | K964607 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron 1000 Cobalt Radiotherapy Terminated |
IWB | K001006 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron 780E Cobalt Radiotherapy Terminated |
IWB | K964606 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron 780C Cobalt Radiotherapy Terminated |
IWB | K001006 |