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

Normalizing Quantitative Electroencephalograph Software

FDA classification

FDA Class 2 ·Normalizing Quantitative Electroencephalograph Software

APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Motex Anti-Fog Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Needle, Emergency Airway

FDA classification

FDA Class 2 ·Needle, Emergency Airway

Controller, Temperature, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Controller, Temperature, Cardiopulmonary Bypass

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Tenaculum, Uterine, Exempt

FDA classification

FDA Class 2 ·Tenaculum, Uterine, Exempt