Kendall - FDA 510(k) Cleared Devices
12
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kendall Gastroenterology & Urology ✕
11 devices
Cleared
Nov 19, 2009
ACUTE AND CHRONIC CATHETER REPAIR KIT
Gastroenterology & Urology
69d
Cleared
Nov 03, 2006
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER...
Gastroenterology & Urology
56d
Cleared
Aug 04, 2006
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE...
Gastroenterology & Urology
119d
Cleared
Jan 06, 2006
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
Gastroenterology & Urology
30d
Cleared
Oct 06, 2005
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
Gastroenterology & Urology
113d
Cleared
Dec 22, 2004
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
Gastroenterology & Urology
26d
Cleared
Nov 05, 2004
KENDALL CO2NFIRM NOW CO2 DETECTOR
Gastroenterology & Urology
45d
Cleared
Sep 27, 2004
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER
Gastroenterology & Urology
73d
Cleared
May 19, 2004
TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR
Gastroenterology & Urology
30d
Cleared
May 17, 2004
NEXT GENERATION SALEM SUMP
Gastroenterology & Urology
90d
Cleared
Feb 20, 2004
PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER
Gastroenterology & Urology
88d