437 results · 19ms · Sources: EU EUDAMED, US FDA

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Selenia Dimensions / 3Dimensions

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Selenia Dimensions 3D System High Resolution Tomosynthesis

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT Revelation with Tomosynthesis Option

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·3Dimensions

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Senographe Pristina 3D

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT B.brilliant with Tomosynthesis Option

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Senographe Pristina 3D and SenoClaire

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Selenia Dimensions/3Dimensions 3D System

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE Xpedition RX/OTW, Apline RX/OTW and Sierra RX Everolimus ELuting Coronary Stent System

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

FDA Pre-Market Approval
FDA Class 3 ·STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Attain Bipolar OTW/Attain OTW LV Lead; Consulta/Percepta Bipolar/Percepta Quadripolar/Serena Bipolar/Serena Quadripolar/

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX ICDS/COROX OTW UP STEROID

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

FDA Pre-Market Approval
FDA Class 3 ·OVATIO CRT & SITUS OTW LV

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

FDA Pre-Market Approval
FDA Class 3 ·OVATIO CRT & SITUS OTW LV