Fresenius Medical Care North America - FDA 510(k) Cleared Devices
43
Total
43
Cleared
0
Denied
42 devices
Cleared
May 30, 2003
FRESENIUS ULTRAFLUX HEMODIALYZER
Gastroenterology & Urology
29d
Cleared
Mar 05, 2003
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
Gastroenterology & Urology
224d
Cleared
Nov 13, 2002
FRESENIUS ICARE MONITORING SYSTEM
Gastroenterology & Urology
225d
Cleared
Aug 16, 2001
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS...
Gastroenterology & Urology
30d
Cleared
Apr 27, 2001
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
Gastroenterology & Urology
88d
Cleared
Apr 05, 2001
FRSENIUS PD IQCARD CYCLER
Gastroenterology & Urology
202d
Cleared
Jan 04, 2001
FRESENIUS OPTIFLUX 200A
Gastroenterology & Urology
52d
Cleared
Dec 04, 2000
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
Gastroenterology & Urology
90d
Cleared
Dec 01, 2000
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
Gastroenterology & Urology
25d
Cleared
Aug 25, 2000
FRESENIUS OPTIFLUX 200NR
Gastroenterology & Urology
30d
Cleared
Jul 28, 2000
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
Gastroenterology & Urology
38d
Cleared
Jun 23, 2000
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP)...
Gastroenterology & Urology
79d
Cleared
Jun 07, 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
Gastroenterology & Urology
98d
Cleared
May 09, 2000
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
Gastroenterology & Urology
88d
Cleared
Sep 03, 1999
FRESENIUS BLOOD VOLUME MONITOR
Gastroenterology & Urology
379d
Cleared
Jul 30, 1999
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW...
Gastroenterology & Urology
88d
Cleared
Aug 27, 1998
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
Gastroenterology & Urology
302d