Fresenius Medical Care North America
Fresenius Medical Care North America holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2025.
Name variants for Fresenius Medical Care North America
as filed with FDA- Fresenius Medical Care North America
- Fresenius Medical Care-North America
Top product codes for Fresenius Medical Care North America
Recent clearances by Fresenius Medical Care North America
- K252181 — AquaA
- K162488 — Optiflux dialyzer
- K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
- K152367 — Optiflux dialyzer
- K123262 — OPTIFLUX ULTRA DIALYZER
- K131611 — FRESENIUS DRY ACID DISSOLUTION UNITS
- K124035 — 2008K@HOME HEMODIALYSIS MACHINE
- K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
- K121599 — CRIT-LINE CLIP (CLIC)
- K120017 — FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
- K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINE
- K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
- K093902 — MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
- K080964 — FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
- K083542 — FRESENIUS STERILE STAY SAFE CAP
- K082414 — OPTIFLUX F250NR, MODEL 0500325E
- K071387 — FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
- K070222 — FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
- K070177 — FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES
- K060734 — FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)
- K050273 — FRESENIUS ART HEMOADSORPTION SYSTEM
- K043363 — FRESENIUS LIBERTY CYCLER
- K043244 — FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
- K041792 — FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
- K041042 — SPLIT SEPTUM INJECTION SITES
- K034064 — FRESENIUS ULTRAFLO HPX HEMODIALYZER
- K031378 — FRESENIUS ULTRAFLUX HEMODIALYZER
- K022412 — FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
- K021060 — FRESENIUS ICARE MONITORING SYSTEM
- K012242 — FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
- K010268 — FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
- K002892 — FRSENIUS PD IQCARD CYCLER
- K003498 — FRESENIUS OPTIFLUX 200A
- K002761 — FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
- K003445 — FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
- K002277 — FRESENIUS OPTIFLUX 200NR
- K001873 — HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
- K001107 — FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
- K000702 — BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
- K000451 — FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
- K982926 — FRESENIUS BLOOD VOLUME MONITOR
- K991520 — FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
- K974090 — 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.