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Sign in to claim this brandAnika Therapeutics, Inc.
United States·US-MF-000041541
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 32 Wiggins Ave, Bedford, United States
- Website
- anika.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Mira Leiwant
- EUDAMED SRN
- US-MF-000041541
- FDA FEI Number
- 3007093114
- DUNS Number
- —
Catalogue (58)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Anika Tissue Tack Fixation System | K222487 | FDA 510(k) | Class II | Active |
| Integrity Implant | K223538 | FDA 510(k) | Class II | Active |
| Tactoset Injectable Bone Substitute | K212083 | FDA 510(k) | Class II | Active |
| Tactoset | K223915 | FDA 510(k) | Class II | Active |
| Staarvisc, Optivisc, And Anikavisc Sodium Hyaluronate | P000046 | FDA PMA | Class III | Active |
| Monovisc Injectable Intra-Articular Device | P090031 | FDA PMA | Class III | Active |
| Orthovisc | P030019 | FDA PMA | Class III | Active |
| Hydrelle | P050033 | FDA PMA | Class III | Active |
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FDA Recalls (13)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 10, 2018 | Z-2423-2018 | — | terminated | Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the film. Over the long term it is possible that product integrity may be compromised. |
| Jul 14, 2005 | Z-1385-05 | — | terminated | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. |
| Jul 14, 2005 | Z-1382-05 | — | terminated | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. |
| Jul 14, 2005 | Z-1383-05 | — | terminated | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. |
| Jul 14, 2005 | Z-1387-05 | — | terminated | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. |
| Jul 14, 2005 | Z-1384-05 | — | terminated | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. |
| Jul 14, 2005 | Z-1386-05 | — | terminated | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. |
| Oct 8, 2003 | Z-0110-04 | — | terminated | Stability failure at the 20 month for viscosity specification |
| Oct 8, 2003 | Z-0109-04 | — | terminated | Stability failure at the 20 month for viscosity specification |
| Oct 8, 2003 | Z-0113-04 | — | terminated | Stability failure at the 20 month for viscosity specification |
| Oct 8, 2003 | Z-0111-04 | — | terminated | Stability failure at the 20 month for viscosity specification |
| Oct 8, 2003 | Z-0112-04 | — | terminated | Stability failure at the 20 month for viscosity specification |
| Oct 8, 2003 | Z-0108-04 | — | terminated | Stability failure at the 20 month for viscosity specification |