Medical Device Manufacturer · US , Waltham, , MA

Fresenius Medical Care North America, Design Cente - FDA 510(k) Clear...

5 submissions · 5 cleared · Since 2010

Recent clearances: FRESENIUS LIBERTY CYCLER, FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT), BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fresenius Medical Care North America, Design Cente Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Sep 09, 2013

FRESENIUS LIBERTY CYCLER

Gastroenterology & Urology · 290d

Cleared Jan 17, 2013

FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR...

Gastroenterology & Urology · 248d

Cleared Jun 15, 2012

BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER...

Gastroenterology & Urology · 88d

Cleared Mar 06, 2012

FRESENIUS 2008T HEMODIALYSIS MACHINE

Gastroenterology & Urology · 14d

Cleared Dec 21, 2010

FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

Gastroenterology & Urology · 186d