Medical Device Manufacturer · US , Walker , MI

Fresenius USA, Inc.

38 submissions · 37 cleared · Since 1984
38
Total
37
Cleared
0
Denied

Fresenius USA, Inc. — FDA 510(k) Submissions

Fresenius USA, Inc. has submitted 38 FDA 510(k) premarket notifications since 1984, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, High Permeability With Or Without Sealed Dialysate System, Dialysate Concentrate For Hemodialysis (liquid Or Powder), System, Dialysate Delivery, Single Patient, Set, Administration, For Peritoneal Dialysis, Disposable, Separator, Automated, Blood Cell And Plasma, Therapeutic . Use the specialty filter in the sidebar to narrow results.

38 devices
1–25 of 38
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
K992275 · KDI Dialyzer, High... · Gastroenterology & Urology
Aug 1999 28d
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
K970700 · MSE Hemodialyzer, Re-use, Low... · Gastroenterology & Urology
Sep 1998 567d
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
K974584 · KDI Dialyzer, High... · Gastroenterology & Urology
May 1998 157d
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
K973378 · CAC Apparatus, Autotransfusion · Anesthesiology
Nov 1997 56d
2008H ON LINE CLEARANCE MONITOR
K961465 · KDI Dialyzer, High... · Gastroenterology & Urology
Jul 1997 442d
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955762 · KPF System, Dialysate... · Gastroenterology & Urology
Jul 1996 226d
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
K961706 · LKN Separator, Automated,... · Gastroenterology & Urology
Jul 1996 90d
FRESENIUS BLOOD TEMPERATURE MONITOR
K941460 · MQS System, Hemodialysis,... · Gastroenterology & Urology
Jul 1996 831d
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955423 · FKP System, Dialysate... · Gastroenterology & Urology
Jun 1996 198d
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE
K930181 · FKP System, Dialysate... · Gastroenterology & Urology
Nov 1995 1049d
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · FIP Subsystem, Water... · Gastroenterology & Urology
Nov 1995 428d
FRESENIUS DIALYSATE ACID CONCENTRATE
K922088 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Oct 1994 896d
FRESENIUS HEMOFLOW, VARIOUS MODELS
K926005 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
Aug 1994 634d
FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
K921456 · FKP System, Dialysate... · Gastroenterology & Urology
Apr 1994 754d
GRANULYTE DIALYSATE CONCENTRATE
K922005 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Mar 1994 700d
FRESENIUS POLYSULFONE DIALYZERS
K921134 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 1993 632d
FRESENIUS PD+ EXCHANGE DEVICE
K915634 · EKX Handpiece, Direct Drive,... · Dental
Jul 1993 562d
FRESENIUS VARIABLE FILL MONITOR
K921052 · KDJ Set, Administration, For... · Gastroenterology & Urology
Feb 1993 357d
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
K912208 · KDJ Set, Administration, For... · Gastroenterology & Urology
Jul 1991 65d
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
K911459 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Jul 1991 105d
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
K904806 · KDJ Set, Administration, For... · Gastroenterology & Urology
Jan 1991 79d
FRESENIUS AS 104 CELL SEPARATOR
K895435 · LKN Separator, Automated,... · Gastroenterology & Urology
Nov 1990 421d
RESUBMITTED MULTIORGAN PERFUSION CANNULA
K902394 · DWF Catheter, Cannula And... · Cardiovascular
Sep 1990 120d
IONOMETER EF-HK AND ACCESSORIES
K901042 · JGS Electrode, Ion Specific,... · Chemistry
Jul 1990 147d
IONOMETER EH-F AND ACCESSORIES
K901040 · JGS Electrode, Ion Specific,... · Chemistry
Jul 1990 135d
Filters