Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX AV ICD SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP,

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CELERITY 2D/3D/PILOT STEROID-ELUTING LV LEAD, COROX (-S/-L) BP STEROID-ELUTING LV LEAD

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SELENIA DIMENSIONS 3D SYSTEM

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SENOGRAPHE PRISTINA 3D

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Senographe Pristina 3D

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Allure RF, Allure Quadra RF, Allure Quadra, Allure, Quadra Allure MP,Quadra Allure MP RF

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity +, Endurity, Endurity Core

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse VR, Ellipse DR, Fortify, Fortify Assura

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

FDA Pre-Market Approval

FDA Class 3 ·Ceramic Total Hip System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT Revelation with Tomosynthesis Option System

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX (R) CERAMIC TOTAL HIP SYSTEM