Company ยท US
Medicel AG
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2025 | K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) Medicel AG, CH | MSS |
| Sep 19, 2023 | K231106 | Accuject Refra Injector AR2900 Medicel AG, CH | MSS |
| Aug 9, 2010 | K101134 | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 Medicel AG | MSS |
| Jul 28, 2009 | K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 Medicel AG | MSS |
| Nov 1, 2007 | K070669 | IOL INJECTOR SET Medicel AG | KYB |
| Jun 17, 2004 | K040837 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE Medicel AG | MSS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2013 | Medicel Ag Product Name: nanoPOINT Injector System, item number 37-0000-08.
Intended to fold and insert a STAAR Surgical Collamer nanoFLEX or Afinity IOLs, through surgical procedure in a human eye. Terminated |
HQL | K070669 |