FDA Registration
Active
🇺🇸 United States
ANIKA THERAPEUTICS, INC.
Reg #: 3007093114
·
FEI: 3007093114
·
Expires 2026
Products
11
Proprietary Names
29
Establishment Types
4
Classifications
11
Registration Details
- Registration Name
- ANIKA THERAPEUTICS, INC.
- Registration Number
- 3007093114
- FEI Number
- 3007093114
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 32 Wiggins Ave
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223860
- PMA Number
- P030019
Owner / Operator
- Firm Name
- ANIKA THERAPEUTICS, INC.
- Operator Number
- 9007935
- Address
- 32 Wiggins Avenue, --
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Inhibitor, Peridural Fibrosis (Adhesion Barrier) | MLQ | Class 3 | Unknown | No | 2008-11-12 |
| Implant, Dermal, For Aesthetic Use | LMH | Class 3 | Unknown | No | 2011-01-20 |
| Aid, Surgical, Viscoelastic | LZP | Class 3 | Ophthalmic | No | 2009-11-24 |
| Acid, Hyaluronic, Intraarticular | MOZ | Class 3 | Unknown | No | 2008-11-12 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-11-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-11-02 |
| Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | OWX | Class 2 | General, Plastic Surgery | No | 2025-09-16 |
| Absorbable Synthetic Wound Dressing | QSZ | Class U | Unknown | No | 2021-05-05 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2019-07-09 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2023-11-02 |
| Barrier, Absorbable, Adhesion | MCN | Class 3 | Unknown | No | 2012-11-06 |
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
Hyalobarrier Gel
Hyaloglide
Hyalobarrier Gel Endo
Monovisc
Ophthalmic Viscoelastic
NuVisc
Anikavisc
Starvisc II
Optivisc
Ophthalin
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device