Kowa Pharmaceuticals America, Inc.
Montgomery, AL, US
Kowa Pharmaceuticals America, Inc. appears in FDA device records in Montgomery, AL. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Kowa Pharmaceuticals America, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Kowa Optimed, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 10 510(k) clearances for Kowa Pharmaceuticals America, Inc. between 1988 and 2002. The busiest year on record is 1995, with 3. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1992 | 1 |
| 1995 | 3 |
| 1996 | 3 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K013805 | KOWA AUTOMATED TONOMETER KT-500 | HKX | Substantially Equivalent | |
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | HPT | Substantially Equivalent | |
| K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 | HKY | Substantially Equivalent | |
| K955442 | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM | HKI | Substantially Equivalent | |
| K954781 | KOWA GENESIS HAND-HELD FUNDUS CAMERA | HKI | Substantially Equivalent | |
| K954780 | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C | HKI | Substantially Equivalent | |
| K954782 | KOWA PORTABLE SLIT LAMP SL-14 & SL-14B | HJO | Substantially Equivalent | |
| K913852 | LASER FLARE METER | HJO | Substantially Equivalent | |
| K880920 | LASER FLARE CELL METER FC-1000 | HJO | Substantially Equivalent | |
| K881219 | AUTOMATIC PERIMETER, AP-340 | HPT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2080939 | 2080939 | Kowa Pharmaceuticals America, Inc. | 530 Industrial Park Blvd, Montgomery, AL 36117 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0636-2021 | Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras. | It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all patient information to be deleted. This could result in delay of treatment. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Kowa Pharmaceuticals America, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain