| AquaA (K252181) | Fresenius Medical Care North America | 2025-09-09 |
| Optiflux dialyzer (K162488) | Fresenius Medical Care North America | 2017-04-06 |
| CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (K152953) | Fresenius Medical Care North America | 2015-11-05 |
| Optiflux dialyzer (K152367) | Fresenius Medical Care North America | 2015-10-29 |
| OPTIFLUX ULTRA DIALYZER (K123262) | Fresenius Medical Care North America | 2014-01-06 |
| FRESENIUS DRY ACID DISSOLUTION UNITS (K131611) | Fresenius Medical Care North America | 2013-08-29 |
| 2008K@HOME HEMODIALYSIS MACHINE (K124035) | Fresenius Medical Care North America | 2013-07-03 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM (K121341) | Fresenius Medical Care North America | 2012-12-06 |
| CRIT-LINE CLIP (CLIC) (K121599) | Fresenius Medical Care-North America | 2012-11-09 |
| FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM (K120017) | Fresenius Medical Care North America | 2012-02-02 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K113427) | Fresenius Medical Care North America | 2011-12-21 |
| FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (K070049) | Fresenius Medical Care North America | 2011-02-03 |
| MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 (K093902) | Fresenius Medical Care North America | 2010-05-27 |
| FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE (K080964) | Fresenius Medical Care North America | 2009-01-14 |
| FRESENIUS STERILE STAY SAFE CAP (K083542) | Fresenius Medical Care North America | 2008-12-29 |
| OPTIFLUX F250NR, MODEL 0500325E (K082414) | Fresenius Medical Care North America | 2008-10-28 |
| FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB (K071387) | Fresenius Medical Care North America | 2007-06-15 |
| FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N (K070222) | Fresenius Medical Care North America | 2007-04-24 |
| FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES (K070177) | Fresenius Medical Care North America | 2007-03-29 |
| FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) (K060734) | Fresenius Medical Care North America | 2006-09-05 |
| FRESENIUS ART HEMOADSORPTION SYSTEM (K050273) | Fresenius Medical Care North America | 2005-06-08 |
| FRESENIUS LIBERTY CYCLER (K043363) | Fresenius Medical Care North America | 2005-03-31 |
| FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR (K043244) | Fresenius Medical Care North America | 2004-12-20 |
| FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 (K041792) | Fresenius Medical Care North America | 2004-09-24 |
| SPLIT SEPTUM INJECTION SITES (K041042) | Fresenius Medical Care North America | 2004-07-16 |
| FRESENIUS ULTRAFLO HPX HEMODIALYZER (K034064) | Fresenius Medical Care North America | 2004-01-30 |
| FRESENIUS ULTRAFLUX HEMODIALYZER (K031378) | Fresenius Medical Care North America | 2003-05-30 |
| FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR (K022412) | Fresenius Medical Care North America | 2003-03-05 |
| FRESENIUS ICARE MONITORING SYSTEM (K021060) | Fresenius Medical Care North America | 2002-11-13 |
| FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS (K012242) | Fresenius Medical Care North America | 2001-08-16 |
| FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 (K010268) | Fresenius Medical Care North America | 2001-04-27 |
| FRSENIUS PD IQCARD CYCLER (K002892) | Fresenius Medical Care North America | 2001-04-05 |
| FRESENIUS OPTIFLUX 200A (K003498) | Fresenius Medical Care North America | 2001-01-04 |
| FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (K002761) | Fresenius Medical Care North America | 2000-12-04 |
| FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (K003445) | Fresenius Medical Care North America | 2000-12-01 |
| FRESENIUS OPTIFLUX 200NR (K002277) | Fresenius Medical Care North America | 2000-08-25 |
| HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 (K001873) | Fresenius Medical Care North America | 2000-07-28 |
| FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) (K001107) | Fresenius Medical Care North America | 2000-06-23 |
| BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR (K000702) | Fresenius Medical Care North America | 2000-06-07 |
| FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 (K000451) | Fresenius Medical Care North America | 2000-05-09 |
| FRESENIUS BLOOD VOLUME MONITOR (K982926) | Fresenius Medical Care North America | 1999-09-03 |
| FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION (K991520) | Fresenius Medical Care North America | 1999-07-30 |
| 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS (K974090) | Fresenius Medical Care North America | 1998-08-27 |