Medicel AG
Medical device manufacturer in Altenrhein, CH.
6510(k) clearances
0PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590)MSS · Traditional | 09/16/2025SE |
| K231106 | Accuject Refra Injector AR2900MSS · Traditional | 09/19/2023SE |
| K101134 | Visian Nanopoint 2.0 Injector Model LP604430MSS · Traditional | 08/09/2010SE |
| K092023 | Naviject SUB2-1P, Model: LP604430MSS · Special | 07/28/2009SE |
| K070669 | Iol Injector SetKYB · Traditional | 11/01/2007SE |
| K040837 | Multiject Injector and Microglide CartridgeMSS · Traditional | 06/17/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1984-2013 Class II | Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and…The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids… | 08/05/2013Terminated |