Medicel Ag

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1984-2013Class IIProduct Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAugust 5, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K252540ACCUJECT Injector Set 2.1-1P (LP604590)September 16, 2025
K231106Accuject Refra Injector AR2900September 19, 2023
K101134VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430August 9, 2010
K092023NAVIJECT SUB2-1P, MODEL: LP604430July 28, 2009
K070669IOL INJECTOR SETNovember 1, 2007
K040837MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGEJune 17, 2004