Medical Device Manufacturer · US , Walker , MI

Fresenius USA, Inc. - FDA 510(k) Cleared Devices

38 submissions · 37 cleared · Since 1984

Recent clearances: FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS, FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX, FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS

38

Total

37

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fresenius USA, Inc. Dental ✕

2 devices

1-2 of 2

Cleared Jul 01, 1993

FRESENIUS PD+ EXCHANGE DEVICE

Cleared Apr 15, 1988

GLANDOSANE (SALIVART) SYNTHETIC SALIVA