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

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

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

Kit, Dna Detection, Human Papillomavirus

FDA classification

FDA Class 3 ·Kit, Dna Detection, Human Papillomavirus

Hepatitis Viral B Dna Detection

FDA classification

FDA Class 3 ·Hepatitis Viral B Dna Detection

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

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLURON

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SELENIA DIMENSIONS 3D SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS