200 results · 28ms · Sources: EU EUDAMED, US FDA

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOCLAIRE

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SELENIA DIMENSIONS 3D SYSTEM

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 800

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

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval
FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM