Anika Therapeutics Inc

FDA Filings

This page includes the latest FDA filings for Anika Therapeutics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USA

NASDAQ

ANIK

DUNS 807613393

Anika Therapeutics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• ANIKA THERAPEUTICS SRL

FDA Registration(s)

• Registration Number: 3007093114
• FEI Number: 3007093114
• Name: ANIKA THERAPEUTICS, INC.
• Owner & Operator: ANIKA THERAPEUTICS, INC.
• Contact Address: 32 Wiggins Avenue --; Bedford MA 01730 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 32 Wiggins Ave ; Bedford, MA 01730 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID M06760001200 Anika Therapeutics, Inc.	Integrity Delivery Instrument, Tissue Tack	2023-11-22
GUDID M06760001180 Anika Therapeutics, Inc.	Integrity Delivery Instrument, Bone Staple	2023-11-22
GUDID M06760001020 Anika Therapeutics, Inc.	Integrity Implant Fixation Kit	2023-11-22
GUDID M06760001220 Anika Therapeutics, Inc.	Integrity Cannula/Obturator Kit	2023-11-17
GUDID 00817337000258 Anika Therapeutics, Inc.	Integrity Implant	2023-11-17
GUDID 00817337000241 Anika Therapeutics, Inc.	Integrity Implant	2023-11-17
GUDID 08033549791063 Anika Therapeutics, Inc.	Epifilm Otologic 1417000	2022-02-14
GUDID 00866142000052 Anika Therapeutics, Inc.	Anikavisc	2022-01-06
GUDID 00817337000128 Anika Therapeutics, Inc.	Ophthalin	2022-01-06
PMA P000046S030 Anika Therapeutics, Inc.	Ophthalin, Anikavisc, Nuvisc	2021-12-22
GUDID 00817337000111 Anika Therapeutics, Inc.	Orthovisc	2021-12-15
GUDID 00817337000104 Anika Therapeutics, Inc.	Monovisc	2021-12-15
PMA P000046S029 Anika Therapeutics, Inc.	Nuvisc, Anikavisc, Ophthalin	2021-10-21
PMA P090031S012 Anika Therapeutics, Inc.	Monovisc High Molecular Weight Hyaluronan	2021-10-13
PMA P090031S011 Anika Therapeutics, Inc.	Monovisc High Molecular Weight Hyaluronan	2021-10-13
PMA P090031S010 Anika Therapeutics, Inc.	Monovisc High Molecular Weight Hyaluronan	2021-09-03
PMA P030019S026 Anika Therapeutics, Inc.	Orthovisc	2021-07-02
PMA P000046S028 Anika Therapeutics, Inc.	Ophthalmic	2021-06-02
GUDID 08033549790776 Anika Therapeutics, Inc.	MeroGel Otologic Packing 1x5cm 1517100	2020-12-21
GUDID 08033549790721 Anika Therapeutics, Inc.	Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm 1517000	2020-12-21
GUDID 08033549790714 Anika Therapeutics, Inc.	Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm 1517002	2020-12-21
PMA P030019S025 Anika Therapeutics, Inc.	Orthovisc	2020-12-08
GUDID 08033549791032 Anika Therapeutics, Inc.	EpiDisc TM Perf Patch Kit 1417151	2020-01-23
GUDID 08033549791025 Anika Therapeutics, Inc.	Epidisc 2pk Otologic 8mm 1417100	2020-01-23
GUDID 08033549791018 Anika Therapeutics, Inc.	Epifilm Otologic 1417000	2020-01-23
GUDID 08033549791001 Anika Therapeutics, Inc.	MeroGel Otologic Packing 1x5cm 1517100	2020-01-23
GUDID 08033549790967 Anika Therapeutics, Inc.	Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm 1517000	2020-01-23
GUDID 08033549790950 Anika Therapeutics, Inc.	Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm 1517002	2020-01-23
PMA P090031S009 Anika Therapeutics, Inc.	Monovisc	2020-01-09
GUDID 00817337000074 Anika Therapeutics, Inc.	Tactoset	2019-10-23
PMA P000046S027 Anika Therapeutics, Inc.	Ophthalmic Viscoelastic	2019-08-28
GUDID 00817337000050 Anika Therapeutics, Inc.	SCS 17-01	2019-07-30
PMN K173008 | MQV ANIKA THERAPEUTICS, INC.	Tactoset	2019-07-09
GUDID 30886158020067 Anika Therapeutics, Inc.	NuVisc	2018-07-06
GUDID 00866142000045 Anika Therapeutics, Inc.	Anikavisc	2018-07-06
GUDID 00866142000038 Anika Therapeutics, Inc.	Optivisc	2018-07-06
GUDID 00866142000021 Anika Therapeutics, Inc.	Staarvisc II	2018-07-06
GUDID 00866142000014 Anika Therapeutics, Inc.	Elevess	2018-07-06
GUDID 00866142000007 Anika Therapeutics, Inc.	Hydrelle	2018-07-06
GUDID 00817337000012 Anika Therapeutics, Inc.	Precision Lens Ophthalmic	2018-07-06
GUDID 07391899830612 Anika Therapeutics, Inc.	Amvisc	2018-03-29
GUDID 07391899830605 Anika Therapeutics, Inc.	Amvisc Plus	2018-03-29
PMN K173008 Anika Therapeutics, Inc.	SCS 17-01	2017-12-26
PMA P090031S008 Anika Therapeutics, Inc.	MONOVISC High Molecular Weight Hyaluronan	2017-08-21
PMA P000046S026 Anika Therapeutics, Inc.	Ophthaalmic Viscoelastic	2017-03-31
PMA P090031S007 Anika Therapeutics, Inc.	MONOVISC	2016-10-04
PMA P090031S006 Anika Therapeutics, Inc.	MONOVISC	2016-02-25
PMA P030019S023 Anika Therapeutics, Inc.	ORTHOVISC	2016-02-25
PMA P050033S018 Anika Therapeutics, Inc.	HYDRELLE DERMAL FILLER	2015-11-03
PMA P050033S020 Anika Therapeutics, Inc.	HYDRELLE	2015-10-22
PMA P090031S004 Anika Therapeutics, Inc.	MONOVISC INJECTABLE INTRA-ARTICULAR DEVICES	2015-05-05
PMA P030019S022 Anika Therapeutics, Inc.	ORTHOVISC INJECTABLE INTRA-ARTICULAR DEVICES	2015-05-05
PMA P050033S019 Anika Therapeutics, Inc.	HYDRELLE	2015-04-10
PMA P090031S003 Anika Therapeutics, Inc.	MONOVISC	2015-02-04
PMN P090031 | MOZ ANIKA THERAPEUTICS, INC.	Monovisc	2014-10-21
PMA P030019S021 Anika Therapeutics, Inc.	ORTHOVISC	2014-07-25
PMA P050033S016 Anika Therapeutics, Inc.	HYDRELLE	2014-07-17
PMA P090031S002 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2014-07-08
PMA P030019S020 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON	2014-07-08
PMA P000046S025 Anika Therapeutics, Inc.	OPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC	2014-07-08
PMA P000046S024 Anika Therapeutics, Inc.	STAARVISC, OPTIVISC AND ANIKAVISC SODIUM HYALURONATE	2014-06-24
PMA P030019S019 Anika Therapeutics, Inc.	ORTHOVISC, HIGH MOLECULAR WEIGHT HYALURONAN	2014-06-12
PMA P090031S001 Anika Therapeutics, Inc.	MONOVISC INJECTABLE INTRA-ARTICULAR DEVICE	2014-06-06
PMA P050033S017 Anika Therapeutics, Inc.	HYDRELLE	2014-05-22
PMA P030019S018 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2014-04-30
PMA P000046S023 Anika Therapeutics, Inc.	NUVISC	2014-04-10
PMA P090031 Anika Therapeutics, Inc.	MONOVISC	2014-02-25
PMA P000046S021 Anika Therapeutics, Inc.	STAARVISC, OPTIVISC, AND ANIKAVISC SODIUM HYALURONATE	2014-01-24
PMA P000046S022 Anika Therapeutics, Inc.	STAARVISC II, SHELLGEL	2014-01-23
PMN K122434 | NHB ANIKA THERAPEUTICS, INC.	Merogel Injectable	2012-11-06
NHB ANIKA THERAPEUTICS, INC.	Sinil Gel	2012-11-06
MCN ANIKA THERAPEUTICS, INC.	Hyaloglide	2012-11-06
MCN ANIKA THERAPEUTICS, INC.	Hyalobarrier Gel	2012-11-06
MCN ANIKA THERAPEUTICS, INC.	Hyalobarrier Gel Endo	2012-11-06
PMA P050033S015 Anika Therapeutics, Inc.	S-15 HYDRELLE	2012-10-22
PMA P000046S015 Anika Therapeutics, Inc.	STAARVISC II & SHELLGEL SODIUM HYAURONATE	2012-03-27
PMA P050033S014 Anika Therapeutics, Inc.	HYDRELLE	2012-03-20
PMA P050033S013 Anika Therapeutics, Inc.	DERMAL FILLER PRODUCT HYDRELLE (ELEVESS)	2012-03-09
PMA P000046S017 Anika Therapeutics, Inc.	STAARVISC II & SHELLGEL SODIUM HYALURONATE	2012-01-17
PMA P030019S014 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2011-12-30
PMA P000046S020 Anika Therapeutics, Inc.	STAARVISC II, OPTIVISC/ANIKAVISC/SODIUM HYALURONATE	2011-12-21
PMA P050033S012 Anika Therapeutics, Inc.	HYDRELLE	2011-09-02
PMA P030019S017 Anika Therapeutics, Inc.	ORTHOVISC	2011-03-18
PMA P000046S019 Anika Therapeutics, Inc.	ANIKA VISC	2011-01-24
LMH ANIKA THERAPEUTICS, INC.	Hydrelle Fine	2011-01-20
LMH ANIKA THERAPEUTICS, INC.	Elevess Light	2011-01-20
PMA P050033S011 Anika Therapeutics, Inc.	HYDRELLE	2010-12-02
PMA P000046S018 Anika Therapeutics, Inc.	STAARVISC II & SHELLGEL SODIUM HYALURONATE	2010-12-01
PMA P050033S006 Anika Therapeutics, Inc.	ELEVESS	2010-11-05
PMA P050033S009 Anika Therapeutics, Inc.	HYDRELLE	2010-08-25
PMA P030019S015 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2010-07-15
PMA P050033S008 Anika Therapeutics, Inc.	ELEVESS	2010-05-24
PMA P000046S016 Anika Therapeutics, Inc.	OPTIVISC	2010-02-12
PMN P810025 | LZP ANIKA THERAPEUTICS, INC.	AMVISC and AMVISC PLUS	2009-11-24
PMA P050033S007 Anika Therapeutics, Inc.	HYDRELLE	2009-06-01
MOZ ANIKA THERAPEUTICS, INC.	Orthovisc-T	2008-11-12
MOZ ANIKA THERAPEUTICS, INC.	Orthovisc mini	2008-11-12
MLQ ANIKA THERAPEUTICS, INC.	INCERT-S	2008-11-12
PMA P050033S002 Anika Therapeutics, Inc.	ELEVESS (AKA COSMETIC TISSUE AUGMENTATION PRODUCT)	2008-04-29
PMA P050033S004 Anika Therapeutics, Inc.	ELEVESS	2008-01-24
PMN P030019 | MOZ ANIKA THERAPEUTICS, INC.	ORTHOVISC	2007-12-27
PMN P000046 | LZP ANIKA THERAPEUTICS, INC.	Starvisc II	2007-12-27
PMN P000046 | LZP ANIKA THERAPEUTICS, INC.	Optivisc	2007-12-27
PMN P000046 | LZP ANIKA THERAPEUTICS, INC.	Ophthalmic Viscoelastic	2007-12-27
PMN P000046 | LZP ANIKA THERAPEUTICS, INC.	NuVisc	2007-12-27
PMN P000046 | LZP ANIKA THERAPEUTICS, INC.	Anikavisc	2007-12-27
PMA P050033S003 Anika Therapeutics, Inc.	COSMETIC TISSUE AUGMENTATION PRODUCT (CTA)	2007-11-19
PMA P030019S009 Anika Therapeutics, Inc.	ORTHOVISC SODIUM HYALURONATE	2007-10-26
PMA P050033S005 Anika Therapeutics, Inc.	ELEVESS	2007-10-03
PMN P050033 | LMH ANIKA THERAPEUTICS, INC.	Hydrelle	2007-08-28
PMN P050033 | LMH ANIKA THERAPEUTICS, INC.	ELEVESS	2007-08-28
PMA P050033S001 Anika Therapeutics, Inc.	COSMETIC TISSUE AUGMENTATION PRODUCT	2007-07-16
PMA P030019S013 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2007-03-15
PMA P050033 Anika Therapeutics, Inc.	HYDRELLE	2006-12-20
PMA P030019S012 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2006-11-08
PMA P000046S014 Anika Therapeutics, Inc.	STAARVISC II AND SHELLGEL SODIUM HYALURONATE	2006-08-24
PMA P030019S010 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2006-08-09
PMA P030019S008 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2006-01-30
PMA P000046S013 Anika Therapeutics, Inc.	STAARVISC II, SHELLGEL AND COEASE	2006-01-24
PMA P000046S012 Anika Therapeutics, Inc.	STAARVISC II SODIUM HYALURONATE	2005-09-26
PMA P000046S011 Anika Therapeutics, Inc.	SHELLGEL SODIUM HYALURONATE	2005-08-03
PMA P030019S006 Anika Therapeutics, Inc.	ORTHOVISC SODIUM HYALURONATE	2004-12-28
PMA P030019S001 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON	2004-08-06
PMA P000046S010 Anika Therapeutics, Inc.	STAARVISC II, SHELLGEL, COEASE SODIUM HYALURONATE	2004-07-16
PMA P030019S005 Anika Therapeutics, Inc.	ORTHOVISC HIGH MODECULAR WEIGHT HYALURNAN	2004-07-14
PMA P030019S004 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2004-06-04
PMA P000046S009 Anika Therapeutics, Inc.	STAARVISC II,SHELLGEL AND COEASE	2004-06-04
PMA P030019S003 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2004-04-09
PMA P030019 Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	2004-02-04
PMA P000046S008 Anika Therapeutics, Inc.	STAARVISC II, SHELLGEL AND COEASE	2003-05-22
PMA P000046S006 Anika Therapeutics, Inc.	STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS	2003-03-18
PMA P000046S007 Anika Therapeutics, Inc.	STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS	2003-03-12
PMA P000046S004 Anika Therapeutics, Inc.	STAARVISC II,SHELLGEL AND COEASE VISCOELASTICS	2002-12-03
PMA P000046S002 Anika Therapeutics, Inc.	STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE	2002-08-30
PMA P000046S003 Anika Therapeutics, Inc.	COEASE SODIUM HYALURONATE	2002-05-08
PMA P000046S001 Anika Therapeutics, Inc.	SHELLGEL(TM) SODIUM HYALURONATE	2001-06-11
PMA P000046 Anika Therapeutics, Inc.	STAARVISC II	2001-04-18

Similar & Related FDA Registered Companies

• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP030019 Supplement NumberS027 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS015 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS014 Date Received10/03/2022 Decision Date11/04/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS013 Date Received06/17/2022 Decision Date07/13/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	6TJR8	ANIKA THERAPEUTICS, INC.
CAGE Code	6TJR8	ANIKA THERAPEUTICS, INC.
SEC	0000898437	Anika Therapeutics, Inc. of DELAWARE
SEC	0001351041	Anika Therapeutics, Inc.