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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CPI SWITCH BOX

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CSI CONTACT LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Foldable Acrylic IOL with OptiEdge

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Multifocal 3-Piece, TECNIS Foldable Acrylic IOL with OptiEdge

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR® Soft Acrylic Posterior Chamber IOL

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CSI(CROFILCON A)EXTENDED WEAR SOFT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CPI SUTURELESS MYOCARDIAL LEAD MODEL 4320

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CSI (CROFILCON A) EXTENDED WEAR SOFT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CALRION CII BIONIC EAR SYSTEM (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CPI MODEL4262 PACE LEAD ,MODIFY TECH MANUAL

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CPI DEXATIP(TM) MODEL 4262 TRANSVENOUS PACING LEAD