Medical Device Manufacturer · US , Abbott Park , IL

Abbott Laboratories - FDA 510(k) Cleared Devices

884 submissions · 869 cleared · Since 1976

Recent clearances: Anti-HCV Next, Anti-HCV Next, ARCHITECT iGentamicin

View 884 510(k) Devices ↓ Official Website

884

Total

869

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Laboratories Gastroenterology & Urology ✕

49 devices

1-12 of 49

Cleared Apr 20, 2012

SAFETY SCREW CONNECTOR

Gastroenterology & Urology · 123d

Cleared May 20, 2005

XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

Gastroenterology & Urology · 79d

Cleared Feb 16, 2005

XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

Gastroenterology & Urology · 29d

Cleared Oct 01, 2004

XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587,...

Gastroenterology & Urology · 72d

Cleared Apr 07, 2004

XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006,...

Gastroenterology & Urology · 23d

Cleared Feb 17, 2004

WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM

Gastroenterology & Urology · 62d

Cleared Dec 10, 2003

SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006,...

Gastroenterology & Urology · 30d

Cleared Nov 07, 1997

FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE

Gastroenterology & Urology · 494d

Cleared Oct 02, 1996

FLEXIFLO POLYG GASTOSTOMY TUBE

Gastroenterology & Urology · 51d

Cleared Apr 13, 1995

FLEXIFLO SIX ENTERAL NUTRITION PUMP SET

Gastroenterology & Urology · 281d

Cleared Mar 01, 1995

FLEXIFLO NASOENTERIC FEEDING TUBE

Gastroenterology & Urology · 1023d

Cleared Jan 09, 1995

FLEXIFLO TUBE PLACEMENT VERIFIER

Gastroenterology & Urology · 972d

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