Company · US
Anika Therapeutics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (2 in 12 months)
13recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2026 | K261869 | Integrity Retractable Implant Inserter (6000127) Anika Therapeutics, Inc. | MBI |
| Sep 2, 2026 | K261311 | HYALOMATRIX Anika Therapeutics, Inc. | QSZ |
| Jun 17, 2025 | K250997 | Integrity Implant Anika Therapeutics, Inc. | OWX |
| Dec 20, 2023 | K231968 | Tactoset® Injectable Bone Substitute Anika Therapeutics, Inc. | MQV |
| Aug 17, 2023 | K223538 | Integrity Implant Anika Therapeutics, Inc. | OWX |
| May 22, 2023 | K223860 | Integrity Bone Staple Fixation System Anika Therapeutics, Inc. | MBI |
| May 8, 2023 | K222487 | Anika Tissue Tack Fixation System Anika Therapeutics, Inc. | GDW |
| Mar 29, 2023 | K223915 | Tactoset Anika Therapeutics, Inc. | MQV |
| Aug 31, 2021 | K212083 | Tactoset Injectable Bone Substitute Anika Therapeutics, Inc. | MQV |
| Jan 30, 2020 | K190956 | SCS 17-01 Anika Therapeutics, Inc. | MQV |
| Dec 26, 2017 | K173008 | SCS 17-01 Anika Therapeutics, Inc. | MQV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Anika Therapeutics, Inc. 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. Terminated |
FRO | K073251 |
| Aug 23, 2005 | Anika Therapeutics, Inc. Amvisc Plus Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY
Product Number: 60081 Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. Amvisc Plus Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY
Product Number: 60051 Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. Amvisc Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY
Product Numbr: 59081 Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. Amvisc Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY
Product Number: 59051 Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. 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 Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml
For European Distribution
Manufactured for Bausch & Lomb Surgical,Irvine,CA and Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics Hialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 mL Sterile. RX. For Intraocular use.
Product Number: 014-180A Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics DomiVisc Sodium Hyaluronate 0.8 mL 12 mg.mL Syringe. Sterile.RX. For intraocular use
Product Numbner; P012-180A
Manufactured for Bausch & Lomb Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics 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 Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics 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 Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics ShellGell Sodium Hyaluronate 0.8mL Syringe,
12 mg/mL. Sterile. Rx. For intraocular use.
Product Number: 1000
Distributed by Cytosol Opthalmics, Inc., Lenick, NC Terminated |
LZP | None listed |