Medical Device Manufacturer · US , Walker , MI

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

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

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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