Synvisc
Synvisc is a Class III device made by Ally Medical Supplies Ltd, approved under FDA PMA P940015 on 8 Aug 1997 and listed in FDA GUDID since 23 Oct 2015 (UDI-DI 05060459970007), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
PMA
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060459970007 | Date23 Oct 2015 | StatusListed |
| United States | FDA PMAAPPR | NumberP940015 | Date8 Aug 1997 | StatusActive |
Official records
- AccessGUDID record 05060459970007
- FDA PMA database P940015
Across registries
- FDA PMA P940015 decided 8 Aug 1997 Active
- FDA GUDID UDI-DI 05060459970007 listed 23 Oct 2015 Listed
Recalls
-
- Terminated Z-0607-2018
Contamination with Methylbacterium thiocyanatum
Timeline
- Approved FDA PMA P940015
- Listed FDA GUDID 05060459970007
- Recall initiated FDA recalls Z-0607-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic name
- Synovial fluid supplementation medium
- Primary DI / UDI-DI
- 05060459970007
- PMA number
- FDA product code
- MOZ
- GMDN term
- Synovial fluid supplementation medium
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MOZ (Acid, Hyaluronic, Intraarticular).
- Hyalgan Acid, Hyaluronic, Intraarticular by Fidia Farmaceutici S.p.A.
- Euflexxa (1% Sodium Hyaluronate) by Ferring Pharmaceuticals, Inc.
- Durolane by BIOVENTUS LLC
- Gel-Syn Acid, Hyaluronic, Intraarticular by Ibsa Institut Biochimique SA
- Monovisc Injectable Intra-Articular Device by Anika Therapeutics, Inc.
- SYNOJOYNT by Mesoblast
- TriVisc by Channel-Markers Medical, LLC
- Synvisc Hylan G-F 20 by Sanofi Genzyme Corp.
- TRILURON by Fidia Farmaceutici S.p.A.
- Supartz by Seikagaku Corp.