Company ยท US
Fresenius USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1999. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 6 |
| FKP | System, Dialysate Delivery, Single Patient | 4 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 4 |
| CAC | Apparatus, Autotransfusion | 3 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 3 |
| CEM | Electrode, Ion Specific, Potassium | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 |
| FIL | System, Dialysate Delivery, Single Pass | 1 |
| FIP | Subsystem, Water Purification | 1 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 |
| KDL | Set, Perfusion, Kidney, Disposable | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| KPF | System, Dialysate Delivery, Semi-Automatic, Peritoneal | 1 |
| LFD | Saliva, Artificial | 1 |
| MQS | System, Hemodialysis, Access Recirculation Monitoring | 1 |
| MSE | Hemodialyzer, Re-Use, Low Flux | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 1999 | K992275 | FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS Fresenius USA, Inc. | KDI |
| Sep 15, 1998 | K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX Fresenius USA, Inc. | MSE |
| May 14, 1998 | K974584 | FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS Fresenius USA, Inc. | KDI |
| Nov 3, 1997 | K973378 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 Fresenius USA, Inc. | CAC |
| Jul 3, 1997 | K961465 | 2008H ON LINE CLEARANCE MONITOR Fresenius USA, Inc. | KDI |
| Jun 13, 1997 | K971274 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET Fresenius AG | CAC |
| Jul 31, 1996 | K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR Fresenius USA, Inc. | LKN |
| Jul 31, 1996 | K960006 | C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM Fresenius AG | CAC |
| Jul 31, 1996 | K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM Fresenius USA, Inc. | KPF |
| Jul 3, 1996 | K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR Fresenius USA, Inc. | MQS |
| Jun 13, 1996 | K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM Fresenius USA, Inc. | FKP |
| Nov 29, 1995 | K944767 | DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER Fresenius USA, Inc. | FIP |
| Nov 29, 1995 | K930181 | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE Fresenius USA, Inc. | FKP |
| Oct 17, 1994 | K922088 | FRESENIUS DIALYSATE ACID CONCENTRATE Fresenius USA, Inc. | KPO |
| Aug 23, 1994 | K926005 | FRESENIUS HEMOFLOW, VARIOUS MODELS Fresenius USA, Inc. | FJI |
| Apr 20, 1994 | K921456 | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM Fresenius USA, Inc. | FKP |
| Mar 30, 1994 | K922005 | GRANULYTE DIALYSATE CONCENTRATE Fresenius USA, Inc. | KPO |
| Dec 2, 1993 | K921134 | FRESENIUS POLYSULFONE DIALYZERS Fresenius USA, Inc. | KDI |
| Jul 1, 1993 | K915634 | FRESENIUS PD+ EXCHANGE DEVICE Fresenius USA, Inc. | EKX |
| Feb 25, 1993 | K921052 | FRESENIUS VARIABLE FILL MONITOR Fresenius USA, Inc. | KDJ |
| Jul 24, 1991 | K912208 | FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE Fresenius USA, Inc. | KDJ |
| Jul 17, 1991 | K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING Fresenius USA, Inc. | KPO |
| Jan 11, 1991 | K904806 | CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR Fresenius USA, Inc. | KDJ |
| Nov 2, 1990 | K895435 | FRESENIUS AS 104 CELL SEPARATOR Fresenius USA, Inc. | LKN |
| Sep 27, 1990 | K902394 | RESUBMITTED MULTIORGAN PERFUSION CANNULA Fresenius USA, Inc. | DWF |
| Jul 31, 1990 | K901042 | IONOMETER EF-HK AND ACCESSORIES Fresenius USA, Inc. | JGS |
| Jul 19, 1990 | K901040 | IONOMETER EH-F AND ACCESSORIES Fresenius USA, Inc. | JGS |
| Jun 28, 1990 | K901039 | IONOMETER EH Fresenius USA, Inc. | CEM |
| Jun 18, 1990 | K901041 | IONOMETER EH-HK AND ACCESSORIES Fresenius USA, Inc. | CEM |
| May 2, 1990 | K895366 | ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE Fresenius USA, Inc. | KNT |
| Dec 27, 1989 | K896111 | FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB Fresenius USA, Inc. | KPO |
| May 11, 1989 | K890824 | FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM Fresenius USA, Inc. | FKP |
| May 11, 1989 | K890329 | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM Fresenius USA, Inc. | FIL |
| Apr 25, 1989 | K892262 | FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M Fresenius USA, Inc. | KDI |
| Jan 26, 1989 | K884609 | EURO-COLLINS SOLUTION SETS Fresenius USA, Inc., DE | KDL |
| Sep 13, 1988 | K883195 | FRESENIUS F8 DIALYZER Fresenius USA, Inc. | KDI |
| Jul 28, 1988 | K881155 | MODEL BPS08 BLOOD PRESSURE MODULE Fresenius USA, Inc. | DXN |
| Apr 15, 1988 | K874106 | GLANDOSANE (SALIVART) SYNTHETIC SALIVA Fresenius USA, Inc., DE | LFD |
| Apr 30, 1985 | K841104 | ENTERNAL FEEDING PUMP BATTERY OPER. Fresenius USA, Inc. | |
| Apr 25, 1984 | K841718 | FREKATHETER VENOUS CATHETERISATION SYS Fresenius USA, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||