Fresenius USA, Inc.
Walker, MI, US
Fresenius USA, Inc. appears in FDA device records in Walker, MI. FDA records list 38 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 38
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 38 510(k) clearances for Fresenius USA, Inc. between 1984 and 1999. The busiest year on record is 1990, with 7. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 1 |
| 1988 | 3 |
| 1989 | 5 |
| 1990 | 7 |
| 1991 | 3 |
| 1993 | 3 |
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 4 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992275 | FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS | KDI | Substantially Equivalent | |
| K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | MSE | Substantially Equivalent | |
| K974584 | FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS | KDI | Substantially Equivalent | |
| K973378 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 | CAC | Substantially Equivalent | |
| K961465 | 2008H ON LINE CLEARANCE MONITOR | KDI | Substantially Equivalent | |
| K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR | LKN | Substantially Equivalent | |
| K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | KPF | Substantially Equivalent | |
| K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR | MQS | Substantially Equivalent | |
| K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | FKP | Substantially Equivalent | |
| K944767 | DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER | FIP | Substantially Equivalent | |
| K930181 | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE | FKP | Substantially Equivalent | |
| K922088 | FRESENIUS DIALYSATE ACID CONCENTRATE | KPO | Substantially Equivalent | |
| K926005 | FRESENIUS HEMOFLOW, VARIOUS MODELS | FJI | Substantially Equivalent | |
| K921456 | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM | FKP | Substantially Equivalent | |
| K922005 | GRANULYTE DIALYSATE CONCENTRATE | KPO | Substantially Equivalent | |
| K921134 | FRESENIUS POLYSULFONE DIALYZERS | KDI | Substantially Equivalent | |
| K915634 | FRESENIUS PD+ EXCHANGE DEVICE | EKX | Substantially Equivalent | |
| K921052 | FRESENIUS VARIABLE FILL MONITOR | KDJ | Substantially Equivalent | |
| K912208 | FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE | KDJ | Substantially Equivalent | |
| K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING | KPO | Substantially Equivalent | |
| K904806 | CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR | KDJ | Substantially Equivalent | |
| K895435 | FRESENIUS AS 104 CELL SEPARATOR | LKN | Substantially Equivalent | |
| K902394 | RESUBMITTED MULTIORGAN PERFUSION CANNULA | DWF | Substantially Equivalent | |
| K901042 | IONOMETER EF-HK AND ACCESSORIES | JGS | Substantially Equivalent | |
| K901040 | IONOMETER EH-F AND ACCESSORIES | JGS | Substantially Equivalent | |
| K901039 | IONOMETER EH | CEM | Substantially Equivalent | |
| K901041 | IONOMETER EH-HK AND ACCESSORIES | CEM | Substantially Equivalent | |
| K895366 | ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE | KNT | Substantially Equivalent | |
| K896111 | FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB | KPO | Substantially Equivalent | |
| K890824 | FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM | FKP | Substantially Equivalent | |
| K890329 | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM | FIL | Substantially Equivalent | |
| K892262 | FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M | KDI | Substantially Equivalent | |
| K884609 | EURO-COLLINS SOLUTION SETS | KDL | Substantially Equivalent | |
| K883195 | FRESENIUS F8 DIALYZER | KDI | Substantially Equivalent | |
| K881155 | MODEL BPS08 BLOOD PRESSURE MODULE | DXN | Substantially Equivalent | |
| K874106 | GLANDOSANE (SALIVART) SYNTHETIC SALIVA | LFD | Substantially Equivalent | |
| K841104 | ENTERNAL FEEDING PUMP BATTERY OPER. | Substantially Equivalent | ||
| K841718 | FREKATHETER VENOUS CATHETERISATION SYS | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CACApparatus, Autotransfusion
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- EKXHandpiece, Direct Drive, Ac-Powered
- MSEHemodialyzer, Re-Use, Low Flux
- LFDSaliva, Artificial
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- KDLSet, Perfusion, Kidney, Disposable
- FIPSubsystem, Water Purification
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal
- FILSystem, Dialysate Delivery, Single Pass
- FKPSystem, Dialysate Delivery, Single Patient
- MQSSystem, Hemodialysis, Access Recirculation Monitoring
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain