Livalo
pitavastatin calcium
Kowa Pharmaceuticals America, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2080939 | 2080939 | Kowa Pharmaceuticals America, Inc. | 1 | Y | 2026-01-01 | 530 Industrial Park Blvd Montgomery AL US 36117 |
| 3011223751 | 3011223751 | KOWA CO. LTD. CHOFU | 1 | N | 2026-01-01 | 3-1, Chofugaoka 3-chome Chofu Tokyo JP 182-0021 |
| 9610828 | 3002807413 | KOWA CO. LTD. | 1 | N | 2020-04-25 | 4-14, NIHONBASHI-HONCHO 3-CHOME CHUO-KU Tokyo JP 103-8433 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 174754 | 1094070775 | K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 | HKY | 1996-06-04 |
| 80632 | 1759354313 | K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 | HKY | 1996-06-04 |
| 80632 | 1313763009 | K222372 | Kowa SL-19 | HJO | 2022-11-21 |
| 174754 | 1338109315 | K222372 | Kowa SL-19 | HJO | 2022-11-21 |
| 174754 | 1175065784 | K191945 | KOWA nonmyd 8 | HKI | 2019-09-10 |
| 174754 | 1409789741 | K190573 | KOWA DR-1a | HKI | 2019-06-04 |
| 80632 | 1614375121 | K190573 | KOWA DR-1a | HKI | 2019-06-04 |
| 174754 | 1952786190 | K190056 | KOWA VK-2s | NFJ | 2019-02-12 |
| 174754 | 1178656279 | K133755 | KOWA SL-17 | HJO | 2014-03-11 |
| 174754 | 1674153654 | K112330 | KOWA VX-20 | HKI | 2012-02-16 |
| 174754 | 1950221022 | K101628 | KOWA NONMYD WX | HKI | 2011-01-26 |
| 174754 | 2066217060 | K091683 | KOWA VX-10 A | HKI | 2009-07-02 |
| 174754 | 1704017039 | K091098 | KOWAGENESIS-DF | HKI | 2009-08-07 |
| 174754 | 1300685115 | K091039 | KOWA, FM-600, MODEL LSS50 | MYC | 2009-08-07 |
| 174754 | 1536680578 | K050271 | KOWA GENESIS-D HAND-HELD RETINAL CAMERA | HKI | 2005-11-03 |
| 10467 | 1426173197 | ||||
| 174754 | 1704913110 | ||||
| 174754 | 1643544254 |
Product Codes Associated With Registrations#
NDC#
PMN#
Kowa SL-19
Kowa Company, Ltd.
KOWA Nonmyd 8
Kowa Company, Ltd.
KOWA DR-1a
Kowa Company, Ltd.
KOWA VK-2s
KOWA Co. Ltd. CHOFU
KOWA SL-17
KOWA CO. LTD.
KOWA VX-20
KOWA CO. LTD.
KOWA NONMYD WX
KOWA CO. LTD.
KOWAGENESIS-DF
KOWA CO. LTD.
KOWA, FM-600, MODEL LSS50
KOWA CO. LTD.
KOWA VX-10 A
KOWA CO. LTD.
MODIFICATION TO KOWA NONMYD ALPHA-DIII
Kowa Co. , Ltd.
KOWA NONMYD ALPHA-DIII
KOWA CO. LTD.
KOWA GENESIS-D
KOWA CO. LTD.
KOWA SL-15
KOWA CO. LTD.
KOWA VX-10I
KOWA CO. LTD.
KOWA NONMYD ALPHA-D
KOWA CO. LTD.
KOWA KT-800
KOWA CO. LTD.
KOWA NONMYD 7, KOWA NONMYD A-D
KOWA CO. LTD.
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
KOWA CO. LTD.
KOWA VX-10
KOWA CO. LTD.
AUTOMATIC VISUAL FIELD PLOTTER AP-125
KOWA OPTIMED, INC.
KOWA HAND-HELD APPLANATION TONOMETER HA-1
KOWA OPTIMED, INC.
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
KOWA OPTIMED, INC.
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
KOWA OPTIMED, INC.
KOWA GENESIS HAND-HELD FUNDUS CAMERA
KOWA OPTIMED, INC.
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
KOWA OPTIMED, INC.
LASER FLARE METER
KOWA OPTIMED, INC.
LASER FLARE CELL METER FC-1000
KOWA OPTIMED, INC.
AUTOMATIC PERIMETER, AP-340
KOWA OPTIMED, INC.
Applications#
GUDID#
KOWA nonmyd 8 - The KOWA nonmyd 8 is intended for use with retinal image capturing without mydriatic.
2016-09-16
KOWA SL-19 - The KOWA SL-19 is intended for use in animal's eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2024-10-08
KOWA SL-19 - KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2023-01-10
KOWA SL-19 - KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2022-12-07
KOWA SL-19 - KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2022-12-07
KOWA SL-19 - KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2022-12-07
KOWA SL-19 - KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2022-12-07
KOWA SL-19 - KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2022-12-07
KOWA SL-15 - KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and an AC-powered stand.
2016-09-16
KOWA SL-17 - KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2016-09-16
KOWA SL-17 - KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2016-09-16
KOWA SL-17 - KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2016-09-16
KOWA SL-17 - KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
2016-09-16
KOWA nonmyd AF - KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic.
2020-01-15
KOWA VK-2s - KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
2019-06-10
KOWA DR-1α - The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
2019-06-10
KOWA VK-2s - KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
2019-06-10
KOWA VK-2s - KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
2019-06-10
KOWA AP-7000 - KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display and output examination results.Static quantitative perimetry examinations and kinetic perimetry examinations are available.
2019-01-08
KOWA GENESIS-Df - KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
2016-09-16
KOWA nonmyd a-DIII - KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface.
2018-02-23
KOWA VX-10 - KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.
2016-09-16
KOWA Applanation Tonometer HA-2 - For the measurement of intraocular pressure in the diagnosis of glaucoma.
2016-09-16
KOWA GENESIS-D - The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
2016-09-16
KOWA FM-600 - KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.
2016-09-16
KOWA KT-800 - The Kowa KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
2016-09-16
KOWA VX-10a - KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.
2016-09-16
KOWA nonmyd WX - KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retina image can be stored to an image filing derive through serial interface.
2016-09-16
KOWA VX-20 - The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.
2016-09-16
KOWA nonmyd 7 - KOWA nonmyd 7 is intended for use with retina image capturing without mydriatic. The retina image can be stored to an image filing equipment through serial interface.
2016-09-16
KOWA nonmyd 8s - The KOWA nonmyd 8s is intended for use with retinal image capturing without mydriatic.
2016-09-16