Medicel Ag
FDA Regulatory Profile
Medicel Ag appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1984-2013, Class II) was initiated on August 5, 2013. Its most recent 510(k) clearance was granted on September 16, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1984-2013 | Class II | Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a ST | August 5, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | September 16, 2025 |
| K231106 | Accuject Refra Injector AR2900 | September 19, 2023 |
| K101134 | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 | August 9, 2010 |
| K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | July 28, 2009 |
| K070669 | IOL INJECTOR SET | November 1, 2007 |
| K040837 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE | June 17, 2004 |