Company
Mani, Inc. - Kiyohara Facility
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2023 | Mani, Inc. - Kiyohara Facility Mani Trocar Kit, Model MTK23S and Model MTK25S
There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula. Terminated |
NGY | None listed |
| Oct 27, 2020 | Mani, Inc. - Kiyohara Facility MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S Terminated |
NGY | None listed |
| Oct 27, 2020 | Mani, Inc. - Kiyohara Facility MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S Terminated |
NGY | None listed |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |