STANICOR, OMNI-STAN,MOD 333B,334A GAMMA

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Mini Ventilation Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED SARNS MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Ventilation Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLOWMETER, OPTIFLO GAS

FDA 510(k)

FDA Class 2 ·Cardiovascular

STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G

FDA 510(k)

FDA Class 2 ·Cardiovascular

GAS-FLOW METER GFL 10

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Gas Control Unit, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Gas Control Unit, Cardiopulmonary Bypass

DEX Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GENERAL PURPOSE KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

FDA 510(k)

FDA Class 2 ·Anesthesiology

Sinobot X1

FDA 510(k)

FDA Class 2 ·Neurology

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4

FDA 510(k)

FDA Class 2 ·Orthopedic

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5

FDA 510(k)

FDA Class 2 ·Orthopedic

airVata™

FDA 510(k)

FDA Class 2 ·Dental