Fresenius USA, Inc. - FDA 510(k) Cleared Devices
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. Gastroenterology & Urology ✕
28 devices
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