| K081936 | SOLEX CATHETER, MODEL SL2593 | August 13, 2008 |
| K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | August 23, 2007 |
| K070161 | QUATTRO CATHETER MODEL IC4593 | February 15, 2007 |
| K063829 | THERMOGARD THERMAL REGULATION SYSTEM | January 22, 2007 |
| K060308 | COOLGARD 3000 | April 26, 2006 |
| K052443 | ICY CATHETER, MODEL IC-3893A | October 17, 2005 |
| K051912 | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETE | October 11, 2005 |
| K030421 | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM | October 23, 2003 |
| K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D | August 1, 2003 |