Vamedis Medical Products Gmbh · 89-08 · GERMANY
For Vamedis Medical Products Gmbh, import alert is 89-08; country is GERMANY; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from 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.