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Anika Therapeutics, Inc.

United States·US-MF-000041541

Last updated September 17, 2026

Information

Country: United States
Address: 32 Wiggins Ave, Bedford, United States
Website: anika.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Mira Leiwant
EUDAMED SRN: US-MF-000041541
FDA FEI Number: 3007093114
DUNS Number: —

Catalogue (58)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
NanoFx PleuriStik Guide Wires	FURS-4101	EUDAMED	Class IIa	Active
MEROGEL 1PK 4x4cm	651140	FDA UDI	Class I	Unknown
Optivisc	600-105	FDA UDI	Class III	Active
Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm	651-140	FDA UDI	Class I	Unknown
Epifilm Otologic	653-200	FDA UDI	Class II	Unknown
Integrity Implant	6000100	FDA UDI	Class II	Active
Amvisc	600-806	FDA UDI	Class III	Active
Anikavisc	6000000	FDA UDI	Class III	Active
Epidisc 2pk Otologic 8mm	653-300	FDA UDI	Class II	Unknown
Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm	651-141	FDA UDI	Class I	Unknown
Elevess	685-310	FDA UDI	Class III	Unknown
MEROGEL 2pk 4x4cm	651141	FDA UDI	Class I	Unknown
EpiDisc TM Perf Patch Kit	653-160	FDA UDI	Class II	Unknown
Orthovisc	630254	FDA UDI	Class III	Active
Integrity Implant	6000114	FDA UDI	Class II	Active
Epifilm Otologic	653-200	FDA UDI	Class II	Unknown
Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm	651-141	FDA UDI	Class I	Unknown
Integrity Delivery Instrument, Tissue Tack	6000120	FDA UDI	Class I	Active
EpiDisc TM Perf Patch Kit	653-160	FDA UDI	Class II	Unknown
Merogel Injectable	640-023	FDA UDI	Class II	Unknown
Ophthalin	6000080	FDA UDI	Class III	Active
Precision Lens Ophthalmic	600-801	FDA UDI	Class III	Active
Amvisc Plus	655-806	FDA UDI	Class III	Active
Integrity Cannula/Obturator Kit	6000122	FDA UDI	Class I	Active
Epifilm Otologic	653-200	FDA UDI	Class II	Unknown
Monovisc	690016	FDA UDI	Class III	Active
Integrity Delivery Instrument, Bone Staple	6000118	FDA UDI	Class I	Active
Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm	651-140	FDA UDI	Class I	Unknown
Integrity Implant Fixation Kit	6000102	FDA UDI	Class II	Active
Staarvisc II	600-809	FDA UDI	Class III	Active
Deployment Skid Cannula Access Tool	6000128	FDA UDI	Class I	Active
Orthovisc	630-254	FDA UDI	Class III	Active
Epidisc 2pk Otologic 8mm	653-300	FDA UDI	Class II	Unknown
Monovisc	690-016	FDA UDI	Class III	Active
Epidisc 2pk Otologic 8mm	653-300	FDA UDI	Class II	Unknown
MeroGel Otologic Packing 1x5cm	651-142	FDA UDI	Class II	Unknown
Hydrelle	685-015	FDA UDI	Class III	Active
Epifilm Otologic	653-200	FDA UDI	Class II	Unknown
MeroGel Otologic Packing 1x5cm	651-142	FDA UDI	Class II	Unknown
EpiDisc TM Perf Patch Kit	653-160	FDA UDI	Class II	Unknown
Tactoset	6000041	FDA UDI	Class II	Active
Anikavisc	600-106	FDA UDI	Class III	Active
NuVisc	600-108	FDA UDI	Class III	Active
Scs 17-01	6000041	FDA UDI	Class II	Active
Integrity Implant	6000101	FDA UDI	Class II	Active
Integrity™ Bone Staple Fixation System	K223860	FDA 510(k)	Class II	Active
Scs 17-01	K173008	FDA 510(k)	Class II	Active
Integrity™ Implant	K250997	FDA 510(k)	Class II	Active
Scs 17-01	K190956	FDA 510(k)	Class II	Active
Tactoset® Injectable Bone Substitute	K231968	FDA 510(k)	Class II	Active

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FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 10, 2018	Z-2423-2018	—	terminated	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.
Jul 14, 2005	Z-1385-05	—	terminated	Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Jul 14, 2005	Z-1382-05	—	terminated	Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Jul 14, 2005	Z-1383-05	—	terminated	Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Jul 14, 2005	Z-1387-05	—	terminated	Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Jul 14, 2005	Z-1384-05	—	terminated	Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Jul 14, 2005	Z-1386-05	—	terminated	Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Oct 8, 2003	Z-0110-04	—	terminated	Stability failure at the 20 month for viscosity specification
Oct 8, 2003	Z-0109-04	—	terminated	Stability failure at the 20 month for viscosity specification
Oct 8, 2003	Z-0113-04	—	terminated	Stability failure at the 20 month for viscosity specification
Oct 8, 2003	Z-0111-04	—	terminated	Stability failure at the 20 month for viscosity specification
Oct 8, 2003	Z-0112-04	—	terminated	Stability failure at the 20 month for viscosity specification
Oct 8, 2003	Z-0108-04	—	terminated	Stability failure at the 20 month for viscosity specification