4,992 results · 34ms · Sources: EU EUDAMED, US FDA

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT(TM)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK MINI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK CD/EASYTRAK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK(R) PRX (TM) II AICD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·L100 ESSENTIO™ SR, L101 ESSENTIO™ DR, L121 ESSENTIO™ EL DR, L200 PROPONENT™ SR, L201 PROPONENT™ DR, L221 PROPONENT™ EL D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Pulse Generator (PG)

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

FDA Pre-Market Approval
FDA Class 3 ·ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, L31

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·EDGEBAND PACER RELAY MODEL 294-03E

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·THINLINE 2 FINELINE 2

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·POLARx FIT Cryoablation Balloon Catheters

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Emblem

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

FDA Pre-Market Approval
FDA Class 3 ·ACUITYX4 Lead Straight, ACUITY X4 Lead Spiral S, ACUITY X4 Lead Spiral L and Suture Sleeve Accessory

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRIZM II AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF UV-ABSORBING PMMA SINGLE-PIECE ANTERIOR CHAMBER

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

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENSES