Medical Device Manufacturer · US , Walker , MI

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

38 submissions · 37 cleared · Since 1984

38

Total

37

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Sep 27, 1990

RESUBMITTED MULTIORGAN PERFUSION CANNULA

Cardiovascular · 120d

Cleared Jul 28, 1988

MODEL BPS08 BLOOD PRESSURE MODULE

Cardiovascular · 132d

Cleared Apr 25, 1984

FREKATHETER VENOUS CATHETERISATION SYS