29 results · 26ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SELECTION AFM, VITATRON C60 DR, C20 SR, T60 DR, AND T20 SR PACING SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEMA FAMILIES & DIVA FAMILIES & SELECTION AFM & C-SERIES & T- SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CLARITY/DA+C & T SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/ SELECTION AFM/TOPAZ 3/II/VITA/VITA 2

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI, ICD, DF-1 ICD, S DR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD, VR ICD; Visia AF M

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

FDA Pre-Market Approval
FDA Class 3 ·Evia HF /HF-T; Entovis HF/ HF-T ; Edora 8 HF-T; Entira 8 HF-1; Etrinsa 8 HF-T; Epyra 8 HF-T; Eluna 8 HF-T; Edora 8HF-T Q

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA classification
FDA Class 3 ·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test