TEMPERATURE CONTROL & MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Heater-Cooler System 3T

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Quantum Heater-Cooler

FDA 510(k)

FDA Class 2 ·Cardiovascular

Controller, Temperature, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Controller, Temperature, Cardiopulmonary Bypass

Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Solo+ Tympanostomy Tube Device (TTD)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COLORADO NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HRVWatch-Mini Wrist Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Citregen Tendon Interference Screw and Citrelock

FDA 510(k)

FDA Class 2 ·Orthopedic

STELLITE COBALT/CHROMIUM BASE METAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

SPINE ALIGN

FDA 510(k)

FDA Class 2 ·Orthopedic

AL-40

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery