# Vamedis Medical Products Gmbh · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Vamedis Medical Products Gmbh · 89-08 · GERMANY, 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 GERMANY; product is Synvisc Hylan Syringe Kits; product code is 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 09/16/2009; address is Landwehrstr. 70A , Munich, Bavaria GERMANY, verified against its source on 2026-09-16.

- **Firm:** Vamedis Medical Products Gmbh _(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:** GERMANY _(verified: appears in the quote below)_
- **Address:** Landwehrstr. 70A , Munich, Bavaria GERMANY _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 87 M - - OZ Acid, hyaluronic, intraarticular _(verified: appears in the quote below)_
- **Product:** Synvisc Hylan Syringe Kits _(verified: appears in the quote below)_
- **FDA notes:** (Product has European label which contains indications for use not yet approved in the United States); Class III; 6/20/2006 _(verified: appears in the quote below)_

## What the source says

> Vamedis Medical Products Gmbh Date Published : 09/16/2009 Landwehrstr. 70A , Munich, Bavaria GERMANY 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 01/30/2019 Desc: Synvisc Hylan Syringe Kits Notes: (Product has European label which contains indications for use not yet approved in the United States); Class III; 6/20/2006

## 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/).