Medicel AG: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medicel AG” (first 2004, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 153 |
| 2024 | 0 | — |
| 2025 | 1 | 35 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medicel AG took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 5 | 5 |
| KYB | Lens, Guide, Intraocular | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Medicel AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | MSS | 2025-09-16 | 35 |
| K231106 | Accuject Refra Injector AR2900 | MSS | 2023-09-19 | 153 |
| K101134 | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 | MSS | 2010-08-09 | 109 |
| K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | MSS | 2009-07-28 | 22 |
| K070669 | IOL INJECTOR SET | KYB | 2007-11-01 | 234 |
| K040837 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE | MSS | 2004-06-17 | 78 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-08-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medicel, S.A. DE C.V. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medicel AG?
FDA lists 6 510(k) clearances under the applicant name “Medicel AG” (first 2004, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medicel AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicel AG is 94 days.
Which FDA product codes appear under Medicel AG?
The most frequent FDA product codes under this applicant name are MSS (Folders And Injectors, Intraocular Lens (Iol), 5); KYB (Lens, Guide, Intraocular, 1).
Next steps
- See all 6 Medicel AG clearances with predicates and recalls
- Run predicate analysis for product code MSS, Medicel AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.