Oped Canada Distribution · 89-08 · CANADA
For Oped Canada Distribution · 89-08 · CANADA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CANADA; product is Matrix II; Bone Growth Stimulator | Matrix II; Bone Growth Stimulator; product code is 87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive; date published is 09/16/2009; address is 344 Townsend Ave , Burlington, ON CANADA, verified against its source on 2026-09-16.
- Firm
- Oped Canada Distribution verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CANADA verified
- Address
- 344 Townsend Ave , Burlington, ON CANADA verified
- Date published
- 09/16/2009 verified
- Product code
- 87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive each item verified
- Product
- Matrix II; Bone Growth Stimulator | Matrix II; Bone Growth Stimulator each item verified
- FDA notes
- The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005 | The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005 each item verified
What the source says
Oped Canada Distribution Date Published : 09/16/2009 344 Townsend Ave , Burlington, ON CANADA 87 L - - OE Stimulator, invasive bone growth Date Published: 06/04/2019 Desc: Matrix II; Bone Growth Stimulator Notes: The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005 87 L - - OF Stimulator, bone growth, non-invasive Date Published: 06/04/2019 Desc: Matrix II; Bone Growth Stimulator Notes: The manufacturers website and the user manual shipped with the product states the product ; Class III; 10/28/2005
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.