Medical Device Manufacturer · US , Walnut Creek , CA

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

3 submissions · 3 cleared · Since 1989

3

Total

3

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Aug 02, 1991

DUAL COMPARTMENT TPN BAG 3 LITER

General Hospital · 115d

Cleared Oct 27, 1989

AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR

General Hospital · 282d

Cleared Oct 27, 1989

AUTOMIX COMPOUNDER Y - ADAPTOR SET

General Hospital · 282d

Data Source

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

Last updated: Apr 28, 2026