ANIKA THERAPEUTICS, INC.

FDA Device Registration & Listing · Bedford, MA, US · Registration 3007093114

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007093114
FEI Number
3007093114
Entity Name
ANIKA THERAPEUTICS, INC.
City/State/Country
Bedford, MA, US
Establishment Address
32 Wiggins Ave, Bedford, MA 01730, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ANIKA THERAPEUTICS, INC. (Owner Number: 9007935)
Owner / Operator Contact Address
32 Wiggins Avenue, --, Bedford, MA 01730, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P090031

All Registered Proprietary Names

INCERT-S Elevess Light Hydrelle Fine AMVISC and AMVISC PLUS Orthovisc-T Orthovisc mini Integrity Bone Staple Fixation System Integrity Delivery Instrument, Tissue Tack Deployment Skid Cannula Access Tool Integrity Delivery Instrument, Bone Staple NanoFx PleuriStik Guide Wire Integrity Cannula/Obturator Kit NanoFx Thumb Tab NanoFx Hand Instrument Integrity Implant Hyalomatrix Tactoset ORTHOVISC Integrity Tissue Tack Fixation System Integrity Implant Hyalobarrier Gel Hyaloglide Hyalobarrier Gel Endo Monovisc

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MLQ Inhibitor, Peridural Fibrosis (Adhesion Barrier) Unknown Class 3 N/A 2008-11-12
LMH Implant, Dermal, For Aesthetic Use Unknown Class 3 N/A 2011-01-20
LZP Aid, Surgical, Viscoelastic Ophthalmic Class 3 886.4275 2009-11-24
MOZ Acid, Hyaluronic, Intraarticular Unknown Class 3 N/A 2008-11-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-11-02
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-11-02
OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2025-09-16
QSZ Absorbable Synthetic Wound Dressing Unknown Class U N/A 2021-05-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2019-07-09
MOZ Acid, Hyaluronic, Intraarticular Unknown Class 3 N/A 2007-12-27
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2023-11-02
OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2023-10-30
MCN Barrier, Absorbable, Adhesion Unknown Class 3 N/A 2012-11-06
MOZ Acid, Hyaluronic, Intraarticular Unknown Class 3 N/A 2014-10-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANIKA THERAPEUTICS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K193295 Parcus Medical, LLC Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor 2020-01-23
K193606 Conmed Corporation Y-Knot OneStep Anchor 2020-01-22
K984200 R. Thomas Grotz, M.D., Inc. STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE 1999-01-21
K171060 Riverpoint Medical OrthoButton AL 2017-06-02
K231867 Paragon 28, Inc. Grappler Suture Anchor System 2023-08-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0530-2015 Abbott Medical Optics Inc (AMO) 3
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
Z-2062-2017 Abbott Medical Optics Inc. (AMO) 3
Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Z-2063-2017 Abbott Medical Optics Inc. (AMO) 3
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Z-2064-2017 Abbott Medical Optics Inc. (AMO) 3
Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Z-2065-2017 Abbott Medical Optics Inc. (AMO) 3
Healon 5 Pro, Part No. 10270015

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007093114. Last updated year: 2026. Please use registration number 3007093114 when referencing this establishment in official correspondence.
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