Medical Device Manufacturer · US , Cambridge , MA

Biogen - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2003

Recent clearances: SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE, INVISIJECT RESUSABLE AUTO-INJECTOR

View 2 510(k) Devices ↓ Official Website

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biogen General Hospital ✕

2 devices

1-2 of 2

Cleared Nov 22, 2004

SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE

General Hospital · 88d

Cleared Nov 05, 2003

INVISIJECT RESUSABLE AUTO-INJECTOR

General Hospital · 91d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 25, 2026