1,779 results · 19ms · Sources: EU EUDAMED, US FDA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRIZM, VENTAK PRIZM 2, VITALITY, VITALITY HE, VITALITY 2, VITALITY AVT, AND CONFIENT FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL 3 CRT-DS, CONTAK RENEWAL 3 HE CRT-DS, LIVIAN CRT-DS, PUNCTUA CRT-DS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He

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

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL 3 CRT-D MODELS H170/H175, CONTAK RENEWAL 3 HE CRT-D MODELS H177/H179, AND MODEL 2845 VERSION 2.2 SOFTWARE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRIZM 2 VR/DR MODELS 1860/1861; VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856; VENTAK PRIZM VR/DR HE MODELS 1852

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ONE PIECE POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CT LUCIA Intraocular Lens (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CHAMBER LENS MODELS 101, 101B, 101T

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Lenstec Softec HD aspheric posterior chamber intraocular lens

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS 3-Piece Acrylic Monofocal

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CHAMBER LENS MODELS 101, 101B, 101T

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES (IOLS)