EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

COOLGARD 3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

CELSIUS CONTROL SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CELSIUS CONTROL SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOLEX CATHETER, MODEL SL2593

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B

FDA 510(k)

FDA Class 2 ·Cardiovascular

THERMOGARD XP THERMAL REGULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARCTIC BLAST INTRAVENOUS FLUID CHILLER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEMPEDY

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hypocore

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console

FDA 510(k)

FDA Class 2 ·Cardiovascular