Medical Device Manufacturer · US , Portland , OR

Bioject, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1987

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bioject, Inc. General Hospital ✕

9 devices

1-9 of 9

Cleared Apr 02, 2009

General Hospital · 90d

Cleared Jun 03, 2005

General Hospital · 74d

Cleared Apr 05, 2001

RECONSTITUTION KIT & VIAL CONNECTOR

General Hospital · 34d

Cleared Mar 08, 2001

General Hospital · 79d

Cleared Jun 22, 2000

General Hospital · 177d

Cleared Mar 05, 1997

BIOJECTOR 2000 MODEL 1B02000

General Hospital · 404d

Cleared Oct 15, 1996

BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)

General Hospital · 74d

Cleared Jun 28, 1994

BIOJECT JET INJECTION SYSTEM

General Hospital · 867d

Cleared Apr 23, 1987

BIOJECTOR SYRINGE SYSTEM

General Hospital · 356d