14 results · 57ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Transvenous Temporary Phrenic Nerve Stimulator

FDA Pre-Market Approval
FDA Class 3 ·AeroPace® System

Transvenous Temporary Phrenic Nerve Stimulator

FDA Pre-Market Approval
FDA Class 3 ·AeroPace® System

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option

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 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)

Digital Breast Tomosynthesis

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

Generator, Shock-Wave, For Pain Relief

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

Digital Breast Tomosynthesis

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

Digital Breast Tomosynthesis

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