Fresenius USA, Inc.
Fresenius USA, Inc. appears in FDA public data with 0 recalls, 38 510(k) clearances, 10 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 4, 1999.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 38
- Inspections
- 10
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K992275 | FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W | August 4, 1999 |
| K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | September 15, 1998 |
| K974584 | FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS | May 14, 1998 |
| K973378 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, P | November 3, 1997 |
| K961465 | 2008H ON LINE CLEARANCE MONITOR | July 3, 1997 |
| K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR | July 31, 1996 |
| K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | July 31, 1996 |
| K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR | July 3, 1996 |
| K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | June 13, 1996 |
| K930181 | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE | November 29, 1995 |
| K944767 | DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER | November 29, 1995 |
| K922088 | FRESENIUS DIALYSATE ACID CONCENTRATE | October 17, 1994 |
| K926005 | FRESENIUS HEMOFLOW, VARIOUS MODELS | August 23, 1994 |
| K921456 | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM | April 20, 1994 |
| K922005 | GRANULYTE DIALYSATE CONCENTRATE | March 30, 1994 |
| K921134 | FRESENIUS POLYSULFONE DIALYZERS | December 2, 1993 |
| K915634 | FRESENIUS PD+ EXCHANGE DEVICE | July 1, 1993 |
| K921052 | FRESENIUS VARIABLE FILL MONITOR | February 25, 1993 |
| K912208 | FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE | July 24, 1991 |
| K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING | July 17, 1991 |