# Medica Outlet · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Medica Outlet · 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 Teosyal; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use; date published is 06/11/2015; address is Toronto Eaton Centre , 1 Dundas St W Suite 2601 , Toronto, Ontario CANADA, verified against its source on 2026-09-16.

- **Firm:** Medica Outlet _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Toronto Eaton Centre , 1 Dundas St W Suite 2601 , Toronto, Ontario CANADA _(verified: appears in the quote below)_
- **Date published:** 06/11/2015 _(verified: appears in the quote below)_
- **Product code:** 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use _(verified: appears in the quote below)_
- **Product:** Teosyal _(verified: appears in the quote below)_
- **FDA notes:** Class III. Teosyal is a dermal filler intended for treating wrinkles; adding contour to facial features; enhancing the lips and eliminating the appearance of aging. The product is marketed on www.medicaoutlet.com. _(verified: appears in the quote below)_

## What the source says

> Medica Outlet Date Published : 06/11/2015 Toronto Eaton Centre , 1 Dundas St W Suite 2601 , Toronto, Ontario CANADA 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 06/11/2015 Desc: Teosyal Notes: Class III. Teosyal is a dermal filler intended for treating wrinkles; adding contour to facial features; enhancing the lips and eliminating the appearance of aging. The product is marketed on www.medicaoutlet.com.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).