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Data / Medical devices / United States / Anika Therapeutics, Inc.

Anika Therapeutics, Inc.: FDA-registered device maker in Bedford, MA, United States, 8 510(k) clearances and 3 PMA approvals

Anika Therapeutics, Inc. is registered with the FDA (registration 3007093114) in Bedford, MA, United States. It lists 9 device types. The FDA files 8 510(k) clearances and 3 PMA approvals under its listings, the newest dated September 17, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Anika Therapeutics, Inc.
FDA registration number
3007093114
Address
32 Wiggins Ave, Bedford, MA, United States, 01730
Owner or operator
ANIKA THERAPEUTICS, INC. (9007935)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
First device listed
December 27, 2007
Registered through
2026
Brand names listed
AMVISC and AMVISC PLUS, Anikavisc, Deployment Skid Cannula Access Tool, Hyalobarrier Gel, Hyalobarrier Gel Endo, Hyalomatrix, Integrity Bone Staple Fixation System, Integrity Cannula/Obturator Kit and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorbable Synthetic Wound DressingQSZUComplaint file establishment, Manufactureraccessdata.fda.gov
Acid, Hyaluronic, IntraarticularMOZ3Manufacturer, Manufacturer for exportaccessdata.fda.gov
Aid, Surgical, ViscoelasticLZP3Contract manufacturer, Manufactureraccessdata.fda.gov
Barrier, Absorbable, AdhesionMCN3Contract manufacturer, Manufacturer for exportaccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Specification developeraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Manufactureraccessdata.fda.gov
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of TendonOWX2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Staple, ImplantableGDW2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 17, 2026K261869Integrity Retractable Implant Inserter (6000127)MBISubstantially EquivalentAnika Therapeutics, Inc.accessdata.fda.gov
September 2, 2026K261311HYALOMATRIXQSZSubstantially EquivalentAnika Therapeutics, Inc.accessdata.fda.gov
June 17, 2025K250997Integrity™ ImplantOWXSubstantially EquivalentAnika Therapeutics, Inc.accessdata.fda.gov
August 17, 2023K223538Integrity ImplantOWXSubstantially EquivalentAnika Therapeutics, Inc.accessdata.fda.gov
May 22, 2023K223860Integrity™ Bone Staple Fixation SystemMBISubstantially EquivalentAnika Therapeutics, Inc.accessdata.fda.gov
May 8, 2023K222487Anika Tissue Tack Fixation SystemGDWSubstantially EquivalentAnika Therapeutics, Inc.accessdata.fda.gov
December 26, 2017K173008SCS 17-01MQVSubstantially EquivalentAnika Therapeutics, Inc.accessdata.fda.gov
December 14, 2007K073251HYALOMATRIX PAQSZSubstantially EquivalentFidia Advanced Biopolymers Srlaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 25, 2014P090031MONOVISCMOZ15August 8, 2023accessdata.fda.gov
February 4, 2004P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONANMOZ23August 28, 2026accessdata.fda.gov
April 18, 2001P000046STAARVISC IILZP31August 28, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 10, 201880291Class IITerminatedHyalomatrix, 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 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.accessdata.fda.gov
July 14, 200532711Not yet classifiedTerminatedStaarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CAProduct sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.accessdata.fda.gov
October 8, 200327457Not yet classifiedTerminatedShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NCStability failure at the 20 month for viscosity specificationaccessdata.fda.gov

Compare with other makers

Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.