Abbott Laboratories - FDA 510(k) Cleared Devices
Recent clearances: Anti-HCV Next, ARCHITECT iGentamicin, Alinity i Rubella IgG
883
Total
868
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Laboratories Gastroenterology & Urology ✕
49 devices
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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