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Fresenius USA, Inc.

38 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS (K992275)Fresenius USA, Inc.1999-08-04
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (K970700)Fresenius USA, Inc.1998-09-15
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS (K974584)Fresenius USA, Inc.1998-05-14
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 (K973378)Fresenius USA, Inc.1997-11-03
2008H ON LINE CLEARANCE MONITOR (K961465)Fresenius USA, Inc.1997-07-03
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955762)Fresenius USA, Inc.1996-07-31
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR (K961706)Fresenius USA, Inc.1996-07-31
FRESENIUS BLOOD TEMPERATURE MONITOR (K941460)Fresenius USA, Inc.1996-07-03
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955423)Fresenius USA, Inc.1996-06-13
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (K930181)Fresenius USA, Inc.1995-11-29
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER (K944767)Fresenius USA, Inc.1995-11-29
FRESENIUS DIALYSATE ACID CONCENTRATE (K922088)Fresenius USA, Inc.1994-10-17
FRESENIUS HEMOFLOW, VARIOUS MODELS (K926005)Fresenius USA, Inc.1994-08-23
FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM (K921456)Fresenius USA, Inc.1994-04-20
GRANULYTE DIALYSATE CONCENTRATE (K922005)Fresenius USA, Inc.1994-03-30
FRESENIUS POLYSULFONE DIALYZERS (K921134)Fresenius USA, Inc.1993-12-02
FRESENIUS PD+ EXCHANGE DEVICE (K915634)Fresenius USA, Inc.1993-07-01
FRESENIUS VARIABLE FILL MONITOR (K921052)Fresenius USA, Inc.1993-02-25
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE (K912208)Fresenius USA, Inc.1991-07-24
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING (K911459)Fresenius USA, Inc.1991-07-17
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR (K904806)Fresenius USA, Inc.1991-01-11
FRESENIUS AS 104 CELL SEPARATOR (K895435)Fresenius USA, Inc.1990-11-02
RESUBMITTED MULTIORGAN PERFUSION CANNULA (K902394)Fresenius USA, Inc.1990-09-27
IONOMETER EF-HK AND ACCESSORIES (K901042)Fresenius USA, Inc.1990-07-31
IONOMETER EH-F AND ACCESSORIES (K901040)Fresenius USA, Inc.1990-07-19
IONOMETER EH (K901039)Fresenius USA, Inc.1990-06-28
IONOMETER EH-HK AND ACCESSORIES (K901041)Fresenius USA, Inc.1990-06-18
ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE (K895366)Fresenius USA, Inc.1990-05-02
FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB (K896111)Fresenius USA, Inc.1989-12-27
FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM (K890329)Fresenius USA, Inc.1989-05-11
FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM (K890824)Fresenius USA, Inc.1989-05-11
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M (K892262)Fresenius USA, Inc.1989-04-25
EURO-COLLINS SOLUTION SETS (K884609)Fresenius USA, Inc.1989-01-26
FRESENIUS F8 DIALYZER (K883195)Fresenius USA, Inc.1988-09-13
MODEL BPS08 BLOOD PRESSURE MODULE (K881155)Fresenius USA, Inc.1988-07-28
GLANDOSANE (SALIVART) SYNTHETIC SALIVA (K874106)Fresenius USA, Inc.1988-04-15
ENTERNAL FEEDING PUMP BATTERY OPER. (K841104)Fresenius USA, Inc.1985-04-30
FREKATHETER VENOUS CATHETERISATION SYS (K841718)Fresenius USA, Inc.1984-04-25

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Every clearance here is in the API, with alerts when new ones post.