10,000 results · 24ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·EPIC VALVE

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX Injectable Gel

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dua

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN STARFIX LEAD

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim, Therapy System, Verify Evaluation System (SNS Urinary Lead)

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SELECTED FAMILIES OF ICDS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Bioprosthesis

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·PROTEGE GPS & RX CAROTID STENT SYSTEMS

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

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL TR

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL LEADS

Material, Dressing, Surgical, Polylactic Acid

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·SELECTSECURE LEAD

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval
FDA Class 3 ·PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·AMVISC & AMVISC PLUS

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels