Medical Device Manufacturer · US , Lexington , MA

Fresenius Medical Care - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2000

Recent clearances: 5008X Hemodialysis System, CRIT-LINE IV SYSTEM, FRESENIUS 2008T HEMODIALYSIS MACHINE

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7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fresenius Medical Care Gastroenterology & Urology ✕

7 devices

1-7 of 7

Cleared Feb 02, 2024

5008X Hemodialysis System

Gastroenterology & Urology · 248d

Cleared Apr 01, 2015

CRIT-LINE IV SYSTEM

Gastroenterology & Urology · 252d

Cleared Oct 21, 2011

FRESENIUS 2008T HEMODIALYSIS MACHINE

Gastroenterology & Urology · 130d

Cleared May 20, 2003

FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES,...

Gastroenterology & Urology · 90d

Cleared Mar 20, 2003

FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS

Gastroenterology & Urology · 178d

Cleared Oct 30, 2002

\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW...

Gastroenterology & Urology · 90d

Cleared Mar 16, 2000

FRESENIUS 2008K

Gastroenterology & Urology · 90d