Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·CRCDx RAS Mutation Detection Assay Kit

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval

FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S670 RAPID EXCHANGE CORONARY STENT SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·TRANSCYTE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EMS-SWISS DOLORCLAST

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EMS SWISS DOLORCLAST

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORETEC HEARTMATE XVE LVAS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ITEC PRELOADED DELIVERY SYSTEM