Anika Therapeutics, Inc.
Bedford, MA, US
ANIKA THERAPEUTICS, INC. appears in FDA device records in Bedford, MA. FDA records list 9 510(k) clearances between and , 90 PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Anika Therapeutics, Inc. between 2017 and 2025. The busiest year on record is 2023, with 5. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 5 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250997 | Integrity™ Implant | OWX | Substantially Equivalent | |
| K231968 | Tactoset® Injectable Bone Substitute | MQV | Substantially Equivalent | |
| K223538 | Integrity Implant | OWX | Substantially Equivalent | |
| K223860 | Integrity™ Bone Staple Fixation System | MBI | Substantially Equivalent | |
| K222487 | Anika Tissue Tack Fixation System | GDW | Substantially Equivalent | |
| K223915 | Tactoset | MQV | Substantially Equivalent | |
| K212083 | Tactoset Injectable Bone Substitute | MQV | Substantially Equivalent | |
| K190956 | SCS 17-01 | MQV | Substantially Equivalent | |
| K173008 | SCS 17-01 | MQV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007093114 | 3007093114 | ANIKA THERAPEUTICS, INC. | 32 Wiggins Ave, Bedford, MA 01730 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QSZAbsorbable Synthetic Wound Dressing
- MOZAcid, Hyaluronic, Intraarticular
- LZPAid, Surgical, Viscoelastic
- MCNBarrier, Absorbable, Adhesion
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- MQVFiller, Bone Void, Calcium Compound
- LMHImplant, Dermal, For Aesthetic Use
- MLQInhibitor, Peridural Fibrosis (Adhesion Barrier)
- OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- LXHOrthopedic Manual Surgical Instrument
- GDWStaple, Implantable
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2423-2018 | Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the management of wounds including: partial and full-thickness wounds; second-degree bums; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use. | 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. | Class II | Terminated | |
| Z-1387-05 | Amvisc Plus Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY Product Number: 60081 | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. | Terminated | ||
| Z-1386-05 | Amvisc Plus Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY Product Number: 60051 | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. | Terminated | ||
| Z-1385-05 | Amvisc Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY Product Numbr: 59081 | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. | Terminated | ||
| Z-1384-05 | Amvisc Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY Product Number: 59051 | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. | Terminated | ||
| Z-1383-05 | ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. | Terminated | ||
| Z-1382-05 | Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. | Terminated | ||
| Z-0113-04 | Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European Distribution Manufactured for Bausch & Lomb Surgical,Irvine,CA and | Stability failure at the 20 month for viscosity specification | Terminated | ||
| Z-0112-04 | Hialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 mL Sterile. RX. For Intraocular use. Product Number: 014-180A | Stability failure at the 20 month for viscosity specification | Terminated | ||
| Z-0111-04 | DomiVisc Sodium Hyaluronate 0.8 mL 12 mg.mL Syringe. Sterile.RX. For intraocular use Product Numbner; P012-180A Manufactured for Bausch & Lomb | Stability failure at the 20 month for viscosity specification | Terminated | ||
| Z-0110-04 | Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe. Sterile. RX. For intraocular use. Product Number: 780A Manufactured for Bausch & Lomb Surgical Inc., Irvin, CA | Stability failure at the 20 month for viscosity specification | Terminated | ||
| Z-0109-04 | Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA | Stability failure at the 20 month for viscosity specification | Terminated | ||
| Z-0108-04 | ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC | Stability failure at the 20 month for viscosity specification | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain