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. Gastroenterology & Urology ✕

28 devices

1-12 of 28

Cleared Aug 04, 1999

FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW...

Gastroenterology & Urology · 28d

Cleared Sep 15, 1998

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX

Gastroenterology & Urology · 567d

Cleared May 14, 1998

FRESENIUS F SERIES HEMOCONCENTRATORS...

Gastroenterology & Urology · 157d

Cleared Jul 03, 1997

2008H ON LINE CLEARANCE MONITOR

Gastroenterology & Urology · 442d

Cleared Jul 31, 1996

PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

Gastroenterology & Urology · 226d

Cleared Jul 31, 1996

P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104...

Gastroenterology & Urology · 90d

Cleared Jul 03, 1996

FRESENIUS BLOOD TEMPERATURE MONITOR

Gastroenterology & Urology · 831d

Cleared Jun 13, 1996

PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

Gastroenterology & Urology · 198d

Cleared Nov 29, 1995

BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE

Gastroenterology & Urology · 1049d

Cleared Nov 29, 1995

DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER

Gastroenterology & Urology · 428d

Cleared Oct 17, 1994

FRESENIUS DIALYSATE ACID CONCENTRATE

Gastroenterology & Urology · 896d

Cleared Aug 23, 1994

FRESENIUS HEMOFLOW, VARIOUS MODELS

Gastroenterology & Urology · 634d