Medical Device Manufacturer · US , Walker , MI

Fresenius USA, Inc. - FDA 510(k) Cleared Devices

38 submissions · 37 cleared · Since 1984

Recent clearances: FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS, FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX, FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS

Total

Cleared

Denied

Fresenius USA, Inc. has 37 FDA 510(k) cleared gastroenterology & urology devices. Based in Walker, US.

Historical record: 37 cleared submissions from 1984 to 1999.

Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Fresenius USA, Inc. is one of 5574 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Fresenius USA, Inc.

38 devices

1-12 of 38

Cleared Aug 04, 1999

FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW...

K992275 · KDI

Gastroenterology & Urology · 28d

Cleared Sep 15, 1998

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX

K970700 · MSE

Gastroenterology & Urology · 567d

Cleared May 14, 1998

FRESENIUS F SERIES HEMOCONCENTRATORS...

K974584 · KDI

Gastroenterology & Urology · 157d

Cleared Nov 03, 1997

C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION...

K973378 · CAC

Anesthesiology · 56d

Cleared Jul 03, 1997

2008H ON LINE CLEARANCE MONITOR

K961465 · KDI

Gastroenterology & Urology · 442d

Cleared Jul 31, 1996

PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

K955762 · KPF

Gastroenterology & Urology · 226d

Cleared Jul 31, 1996

P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104...

K961706 · LKN

Gastroenterology & Urology · 90d

Cleared Jul 03, 1996

FRESENIUS BLOOD TEMPERATURE MONITOR

K941460 · MQS

Gastroenterology & Urology · 831d

Cleared Jun 13, 1996

PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

K955423 · FKP

Gastroenterology & Urology · 198d

Cleared Nov 29, 1995

BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE

K930181 · FKP

Gastroenterology & Urology · 1049d

Cleared Nov 29, 1995

DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER

K944767 · FIP

Gastroenterology & Urology · 428d

Cleared Oct 17, 1994

FRESENIUS DIALYSATE ACID CONCENTRATE

K922088 · KPO

Gastroenterology & Urology · 896d

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Fresenius USA, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Fresenius USA, Inc.

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