FDA 510(k) Applications Submitted by FRESENIUS MEDICAL CARE NORTH AMERICA

FDA 510(k) Number Submission Date Device Name Applicant
K002892 09/15/2000 FRSENIUS PD IQCARD CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA
K010268 01/29/2001 FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 FRESENIUS MEDICAL CARE NORTH AMERICA
K000451 02/11/2000 FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 FRESENIUS MEDICAL CARE NORTH AMERICA
K000702 03/01/2000 BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR FRESENIUS MEDICAL CARE NORTH AMERICA
K001107 04/05/2000 FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) FRESENIUS MEDICAL CARE NORTH AMERICA
K041042 04/22/2004 SPLIT SEPTUM INJECTION SITES FRESENIUS MEDICAL CARE NORTH AMERICA
K031378 05/01/2003 FRESENIUS ULTRAFLUX HEMODIALYZER FRESENIUS MEDICAL CARE NORTH AMERICA
K991520 05/03/1999 FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION FRESENIUS MEDICAL CARE NORTH AMERICA
K041792 07/02/2004 FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 FRESENIUS MEDICAL CARE NORTH AMERICA
K012242 07/17/2001 FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS FRESENIUS MEDICAL CARE NORTH AMERICA
K002277 07/26/2000 FRESENIUS OPTIFLUX 200NR FRESENIUS MEDICAL CARE NORTH AMERICA
K002761 09/05/2000 FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS FRESENIUS MEDICAL CARE NORTH AMERICA
K003445 11/06/2000 FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 FRESENIUS MEDICAL CARE NORTH AMERICA
K003498 11/13/2000 FRESENIUS OPTIFLUX 200A FRESENIUS MEDICAL CARE NORTH AMERICA
K043244 11/23/2004 FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR FRESENIUS MEDICAL CARE NORTH AMERICA
K043363 12/07/2004 FRESENIUS LIBERTY CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA
K034064 12/31/2003 FRESENIUS ULTRAFLO HPX HEMODIALYZER FRESENIUS MEDICAL CARE NORTH AMERICA
K001873 06/20/2000 HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 FRESENIUS MEDICAL CARE NORTH AMERICA
K022412 07/24/2002 FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR FRESENIUS MEDICAL CARE NORTH AMERICA
K131611 06/03/2013 FRESENIUS DRY ACID DISSOLUTION UNITS FRESENIUS MEDICAL CARE NORTH AMERICA
K152367 08/21/2015 Optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA
K162488 09/07/2016 Optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA
K152953 10/07/2015 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER FRESENIUS MEDICAL CARE NORTH AMERICA
K123262 10/18/2012 OPTIFLUX ULTRA DIALYZER FRESENIUS MEDICAL CARE NORTH AMERICA
K113427 11/21/2011 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA
K124035 12/28/2012 2008K@HOME HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA
K982926 08/20/1998 FRESENIUS BLOOD VOLUME MONITOR FRESENIUS MEDICAL CARE NORTH AMERICA
K050273 02/07/2005 FRESENIUS ART HEMOADSORPTION SYSTEM FRESENIUS MEDICAL CARE NORTH AMERICA
K082414 08/21/2008 OPTIFLUX F250NR, MODEL 0500325E FRESENIUS MEDICAL CARE NORTH AMERICA
K083542 11/28/2008 FRESENIUS STERILE STAY SAFE CAP FRESENIUS MEDICAL CARE NORTH AMERICA
K070049 01/04/2007 FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR FRESENIUS MEDICAL CARE NORTH AMERICA
K070177 01/18/2007 FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES FRESENIUS MEDICAL CARE NORTH AMERICA
K070222 01/24/2007 FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N FRESENIUS MEDICAL CARE NORTH AMERICA
K060734 03/20/2006 FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) FRESENIUS MEDICAL CARE NORTH AMERICA
K080964 04/04/2008 FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA
K071387 05/18/2007 FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB FRESENIUS MEDICAL CARE NORTH AMERICA
K021060 04/02/2002 FRESENIUS ICARE MONITORING SYSTEM FRESENIUS MEDICAL CARE NORTH AMERICA
K093902 12/22/2009 MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 FRESENIUS MEDICAL CARE NORTH AMERICA
K974090 10/29/1997 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS FRESENIUS MEDICAL CARE NORTH AMERICA


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