Medicel AG is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Medicel AG - FDA 510(k) Cleared Devices
Recent clearances: ACCUJECT Injector Set 2.1-1P (LP604590), Accuject Refra Injector AR2900
6
Total
6
Cleared
0
Denied
Medicel AG has 6 FDA 510(k) cleared medical devices. Based in Hasbrouck Heights, US.
Latest FDA clearance: Sep 2025. Active since 2004. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Medicel AG Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Staar Surgical as regulatory consultant.
FDA 510(k) Regulatory Record - Medicel AG
6 devices
Cleared
Sep 16, 2025
ACCUJECT Injector Set 2.1-1P (LP604590)
Ophthalmic
35d
Cleared
Sep 19, 2023
Accuject Refra Injector AR2900
Ophthalmic
153d
Cleared
Aug 09, 2010
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
Ophthalmic
109d
Cleared
Jul 28, 2009
NAVIJECT SUB2-1P, MODEL: LP604430
Ophthalmic
22d
Cleared
Nov 01, 2007
IOL INJECTOR SET
Ophthalmic
234d
Cleared
Jun 17, 2004
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
Ophthalmic
78d