Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

48 results for "Fresenius Medical Care North America"
1–24 of 48
Search insights Median review: 88d Cleared: 100% Top manufacturer: Fresenius Medical Care North America Lead specialty: Gastroenterology & Urology
Cleared Sep 09, 2025
AquaA
K252181 · FIP
Fresenius Medical Care North America
Gastroenterology & Urology · 60d
Cleared Apr 06, 2017
Optiflux dialyzer
K162488 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 211d
Cleared Nov 05, 2015
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K152953 · KOC
Fresenius Medical Care North America
Gastroenterology & Urology · 29d
Cleared Oct 29, 2015
Optiflux dialyzer
K152367 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 69d
Cleared Jan 06, 2014
OPTIFLUX ULTRA DIALYZER
K123262 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 445d
Cleared Sep 09, 2013
FRESENIUS LIBERTY CYCLER
K123630 · FKX
Fresenius Medical Care North America,...
Gastroenterology & Urology · 290d
Cleared Aug 29, 2013
FRESENIUS DRY ACID DISSOLUTION UNITS
K131611 · KPO
Fresenius Medical Care North America
Gastroenterology & Urology · 87d
Cleared Jul 03, 2013
2008K@HOME HEMODIALYSIS MACHINE
K124035 · ONW
Fresenius Medical Care North America
Gastroenterology & Urology · 187d
Cleared Jan 17, 2013
FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR...
K121421 · ONW
Fresenius Medical Care North America,...
Gastroenterology & Urology · 248d
Cleared Dec 06, 2012
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
K121341 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 217d
Cleared Nov 09, 2012
CRIT-LINE CLIP (CLIC)
K121599 · KOC
Fresenius Medical Care North America
Gastroenterology & Urology · 161d
Cleared Jun 15, 2012
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER...
K120823 · FJK
Fresenius Medical Care North America,...
Gastroenterology & Urology · 88d
Cleared Mar 06, 2012
FRESENIUS 2008T HEMODIALYSIS MACHINE
K120505 · KDI
Fresenius Medical Care North America,...
Gastroenterology & Urology · 14d
Cleared Feb 02, 2012
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
K120017 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Dec 21, 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
K113427 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Feb 03, 2011
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
K070049 · ONW
Fresenius Medical Care North America
Gastroenterology & Urology · 1491d
Cleared Dec 21, 2010
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
K101715 · KDI
Fresenius Medical Care North America,...
Gastroenterology & Urology · 186d
Cleared May 27, 2010
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
K093902 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 156d
Cleared Jan 14, 2009
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
K080964 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 285d
Cleared Dec 29, 2008
FRESENIUS STERILE STAY SAFE CAP
K083542 · KDJ
Fresenius Medical Care North America
Gastroenterology & Urology · 31d
Cleared Oct 28, 2008
OPTIFLUX F250NR, MODEL 0500325E
K082414 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 68d
Cleared Jun 15, 2007
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
K071387 · KPO
Fresenius Medical Care North America
Gastroenterology & Urology · 28d
Cleared Apr 24, 2007
FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
K070222 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 90d
Cleared Mar 29, 2007
FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES
K070177 · KPO
Fresenius Medical Care North America
Gastroenterology & Urology · 70d