184 results · 19ms · Sources: EU EUDAMED, US FDA

ALPHA OMEGA DUAL COOLER-HEATER

FDA 510(k)
FDA Class 2 ·Cardiovascular

PTI HEART-CHILL POUCH/PAD SLING (STERILE)

FDA 510(k)
FDA Class 2 ·Cardiovascular

JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

TEMPERATURE CONTROL & MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

Heater-Cooler System 3T

FDA 510(k)
FDA Class 2 ·Cardiovascular

INSTANT AIR

FDA 510(k)
FDA Class 2 ·Anesthesiology

MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET

FDA 510(k)
FDA Class 2 ·Anesthesiology

ECMO-TEMP (TM) BLOOD WARMING DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120

FDA 510(k)
FDA Class 2 ·Cardiovascular

POLYSTAN HEATER-COOLER UNIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

HEATER COOLER UNIT, MODEL HCU 30

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320

FDA 510(k)
FDA Class 2 ·Cardiovascular

Emergency Transtracheal Airway Catheter

FDA 510(k)
FDA Class 2 ·Anesthesiology

Quantum Heater-Cooler

FDA 510(k)
FDA Class 2 ·Cardiovascular

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE