Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA classification

FDA Class 3 ·Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Navion Thoracic Stent Graft System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulation

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN RT CONTINUOUS GLUCOSE MONITORING SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION

LM-150HT LIGHT SOURCE

FDA 510(k)

FDA Class 3 ·Unknown

MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB

FDA 510(k)

FDA Class 3 ·Cardiovascular

CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA

FDA 510(k)

FDA Class 3 ·Cardiovascular

CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZWEYMULLER CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

STANICOR GAMMA 333B/334A

FDA 510(k)

FDA Class 3 ·Cardiovascular

VASCO TIP/VASCOFLANGE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL SF. D&SX.D PACEMAKER LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular