FCL Health Solutions Ltd · 89-08 · UNITED KINGDOM
For FCL Health Solutions Ltd · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; product is Hyaluronic Acid; product code is 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 02/16/2018; address is Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- FCL Health Solutions Ltd 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
- UNITED KINGDOM verified
- Address
- Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM verified
- Date published
- 02/16/2018 verified
- Product code
- 87 M - - OZ Acid, hyaluronic, intraarticular verified
- Product
- Hyaluronic Acid verified
- FDA notes
- Class III; verified
What the source says
FCL Health Solutions Ltd Date Published : 02/16/2018 Hawthorns House , Hawthorns Business Centre; Halfords Lane , Smethwick, West Midlands UNITED KINGDOM 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 02/16/2018 Desc: Hyaluronic Acid Notes: Class III;
— 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.