Reference Source

Q-Med AB · 89-08 · SWEDEN

For Q-Med AB, import alert is 89-08; country is SWEDEN; 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 Perlane Sodium Hyaluronic Acid; product code is 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 09/16/2009; address is Seminariegatan 21 , Uppsala, Uppsala Lan SWEDEN, verified against its source on 2026-09-30.

Firm
Q-Med AB 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
SWEDEN verified
Address
Seminariegatan 21 , Uppsala, Uppsala Lan SWEDEN verified
Date published
09/16/2009 verified
Product code
87 M - - OZ Acid, hyaluronic, intraarticular verified
Product
Perlane Sodium Hyaluronic Acid verified
FDA notes
6/3/2002 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Q-Med AB Date Published : 09/16/2009 Seminariegatan 21 , Uppsala, Uppsala Lan SWEDEN

— 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: 06/04/2019 Desc: Perlane Sodium Hyaluronic Acid Notes: 6/3/2002

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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.