Kowa Co., Ltd.
Chuo-Ku, Tokyo, JP
Kowa Co. , Ltd. appears in FDA device records in Chuo-Ku, Tokyo, JP. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Kowa Co., Ltd. between 2005 and 2014. The busiest year on record is 2009, with 4. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2006 | 2 |
| 2008 | 2 |
| 2009 | 4 |
| 2011 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133755 | KOWA SL-17 | HJO | Substantially Equivalent | |
| K101628 | KOWA NONMYD WX | HKI | Substantially Equivalent | |
| K091098 | KOWAGENESIS-DF | HKI | Substantially Equivalent | |
| K091039 | KOWA, FM-600, MODEL LSS50 | MYC | Substantially Equivalent | |
| K091683 | KOWA VX-10 A | HKI | Substantially Equivalent | |
| K083387 | MODIFICATION TO KOWA NONMYD ALPHA-DIII | HKI | Substantially Equivalent | |
| K082767 | KOWA NONMYD ALPHA-DIII | HKI | Substantially Equivalent | |
| K080681 | KOWA GENESIS-D | HKI | Substantially Equivalent | |
| K063640 | KOWA SL-15 | HJO | Substantially Equivalent | |
| K062356 | KOWA NONMYD ALPHA-D | HKI | Substantially Equivalent | |
| K053026 | KOWA NONMYD 7, KOWA NONMYD A-D | HKI | Substantially Equivalent | |
| K050271 | KOWA GENESIS-D HAND-HELD RETINAL CAMERA | HKI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
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.
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Data as of , FDA export datePage updated Source: openFDA, public domain