Durolane - N/A
2026-10-15
NUVARA SRL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| NUVARA SRL | 5 | N | 2027-01-01 | Via Luigi Orlando 257 Giarre Catania IT 95014 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 353444 | 2067380854 | P980044 | SUPARTZ FX | MOZ | 2001-01-24 |
| 353444 | 1246525483 | P940015 | SYNVISC ONE | MOZ | 1997-08-08 |
| 353444 | 1409396831 | P170007 | DUROLANE | MOZ | 2017-08-29 |
| 353444 | 1514449608 | P140029 | Restylane Refyne, Restylane Defyne | LMH | 2016-12-09 |
| 353444 | 1300932717 | P110033 | JUVEDERM VOLUMA XC | LMH | 2013-10-22 |
| 353444 | 1162100864 | P090031 | MONOVISC | MOZ | 2014-02-25 |
| 353444 | 1187725400 | P050052 | RADIESSE INJECTABLE IMPLANT | LMH | 2006-12-22 |
| 353444 | 1674642007 | P040024 | RESTYLANE INJECTABLE GEL | LMH | 2005-03-25 |
| 353444 | 1496411465 | P030050 | SCULPTRA AND SCULPTRA AESTHETIC | LMH | 2004-08-03 |
| 353444 | 1380342178 | P030019 | ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN | MOZ | 2004-02-04 |
| 353444 | 1354559453 | P010029 | EUFLEXXA (1% SODIUM HYALURONATE) | MOZ | 2004-12-03 |
Product Codes Associated With Registrations#
GUDID#
Euflexxa - N/A
2026-10-15
Juvederm Volbella - N/A
2026-10-15
Juvederm Volux - N/A
2026-10-15
Juvederm Voluma - N/A
2026-10-15
Monovisc - N/A
2026-10-15
Orthovisc - N/A
2026-10-15
Radiesse - N/A
2026-10-15
Restylane Lido - N/A
2026-10-15
Restylane Lyft - N/A
2026-10-15
Restylane Refyne - N/A
2026-10-15
Restylane Kysse - N/A
2026-10-15
Restylane Defyne - N/A
2026-10-15
Sculptra - N/A
2026-10-15
Supartz - N/A
2026-10-15
Synvisc - N/A
2026-10-15
Synvisc One - N/A
2026-10-15