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"

25–48 of 48

Search insights Median review: 88d Cleared: 100% Top manufacturer: Fresenius Medical Care North America Lead specialty: Gastroenterology & Urology

Cleared Sep 05, 2006

FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031

Fresenius Medical Care North America

Gastroenterology & Urology · 169d

Cleared Jun 08, 2005

FRESENIUS ART HEMOADSORPTION SYSTEM

Fresenius Medical Care North America

Gastroenterology & Urology · 121d

Cleared Mar 31, 2005

FRESENIUS LIBERTY CYCLER

Fresenius Medical Care North America

Gastroenterology & Urology · 114d

Cleared Dec 20, 2004

FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR

Fresenius Medical Care North America

Gastroenterology & Urology · 27d

Cleared Sep 24, 2004

FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211

Fresenius Medical Care North America

Gastroenterology & Urology · 84d

Cleared Jul 16, 2004

SPLIT SEPTUM INJECTION SITES

Fresenius Medical Care North America

General Hospital · 85d

Cleared Jan 30, 2004

FRESENIUS ULTRAFLO HPX HEMODIALYZER

Fresenius Medical Care North America

Gastroenterology & Urology · 30d

Cleared May 30, 2003

FRESENIUS ULTRAFLUX HEMODIALYZER

Fresenius Medical Care North America

Gastroenterology & Urology · 29d

Cleared Mar 05, 2003

FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR

Fresenius Medical Care North America

Gastroenterology & Urology · 224d

Cleared Nov 13, 2002

FRESENIUS ICARE MONITORING SYSTEM

Fresenius Medical Care North America

Gastroenterology & Urology · 225d

Cleared Aug 16, 2001

FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS...

Fresenius Medical Care North America

Gastroenterology & Urology · 30d

Cleared Apr 27, 2001

FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9

Fresenius Medical Care North America

Gastroenterology & Urology · 88d

Cleared Apr 05, 2001

FRSENIUS PD IQCARD CYCLER

Fresenius Medical Care North America

Gastroenterology & Urology · 202d

Cleared Jan 04, 2001

FRESENIUS OPTIFLUX 200A

Fresenius Medical Care North America

Gastroenterology & Urology · 52d

Cleared Dec 04, 2000

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

Fresenius Medical Care North America

Gastroenterology & Urology · 90d

Cleared Dec 01, 2000

FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2

Fresenius Medical Care North America

Gastroenterology & Urology · 25d

Cleared Aug 25, 2000

FRESENIUS OPTIFLUX 200NR

Fresenius Medical Care North America

Gastroenterology & Urology · 30d

Cleared Jul 28, 2000

HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0

Fresenius Medical Care North America

Gastroenterology & Urology · 38d

Cleared Jun 23, 2000

FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP)...

Fresenius Medical Care North America

Gastroenterology & Urology · 79d

Cleared Jun 07, 2000

BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR

Fresenius Medical Care North America

Gastroenterology & Urology · 98d

Cleared May 09, 2000

FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290

Fresenius Medical Care North America

Gastroenterology & Urology · 88d

Cleared Sep 03, 1999

FRESENIUS BLOOD VOLUME MONITOR

Fresenius Medical Care North America

Gastroenterology & Urology · 379d

Cleared Jul 30, 1999

FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW...

Fresenius Medical Care North America

Gastroenterology & Urology · 88d

Cleared Aug 27, 1998

95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS

Fresenius Medical Care North America

Gastroenterology & Urology · 302d