# Storz Medical, AG · 89-08 · SWITZERLAND — FDA import alert red lists: firms subject to detention without physical examination

For Storz Medical, AG · 89-08 · SWITZERLAND, 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 SWITZERLAND; product is D-Actor 50 Shockwave device; product code is 89 O - - OV Evopace system and accessories; date published is 04/27/2010; address is Lohstampfestrasse 8 , Tagerwilen, Thurgau SWITZERLAND, verified against its source on 2026-09-16.

- **Firm:** Storz Medical, AG _(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:** SWITZERLAND _(verified: appears in the quote below)_
- **Address:** Lohstampfestrasse 8 , Tagerwilen, Thurgau SWITZERLAND _(verified: appears in the quote below)_
- **Date published:** 04/27/2010 _(verified: appears in the quote below)_
- **Product code:** 89 O - - OV Evopace system and accessories _(verified: appears in the quote below)_
- **Product:** D-Actor 50 Shockwave device _(verified: appears in the quote below)_
- **FDA notes:** Class III _(verified: appears in the quote below)_

## What the source says

> Storz Medical, AG Date Published : 04/27/2010 Lohstampfestrasse 8 , Tagerwilen, Thurgau SWITZERLAND 89 O - - OV Evopace system and accessories Date Published: 04/27/2010 Desc: D-Actor 50 Shockwave device Notes: Class III

## 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/).