128 results · 20ms · Sources: EU EUDAMED, US FDA

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Symfony PLUS Extended Range of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range of

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval
FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera Intraocular Lens

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera intraocular lens (IOL)

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera IOL Aperture Mask

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Acrysof IQ Aspheric UV absorbing IOL with the UltraSert Pre-Loaded Delivery System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System AU00T0

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spectra WaveWriter Spinal Cord Stimulator Systems, Precision Spectra, Pre-Weld Test Equipment System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS Element Plus Everolimus-Eluting Plaatinum Chromium Coronary Stent System (Monorail and Over-the-Wire), PROMUS PRE

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·Model 203 Life Pulse High Frequency Ventilator