Vamedis Medical Products Gmbh · 89-08 · GERMANY
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
- 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
- Address
- Landwehrstr. 70A , Munich, Bavaria GERMANY verified
- Date published
- 09/16/2009 verified
- Product code
- 87 M - - OZ Acid, hyaluronic, intraarticular verified
- Product
- Synvisc Hylan Syringe Kits verified
- FDA notes
- (Product has European label which contains indications for use not yet approved in the United States); Class III; 6/20/2006 verified
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
— 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.