447 results · 25ms · Sources: EU EUDAMED, US FDA

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·PERIMOUNT PERICARDIAL BIOPROSTHESES

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·DURAFLEX LOW PRESSURE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·BIOPROSTHESIS MODEL 2625,6625, VALVED CONDUIT MODEL 4300

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Durata, Optisure,

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM, IMPLANT AND SIZING TOOL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Tendril MRI

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

FDA Pre-Market Approval
FDA Class 3 ·Isoflex

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

FDA Pre-Market Approval
FDA Class 3 ·QuickFlex u, Quartet

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

FDA Pre-Market Approval
FDA Class 3 ·Tendrill SDX, OptiSense, Tendrill STS, Tendril ST.

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GELSYN-3

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval
FDA Class 3 ·LEGOO

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·EUFLEXXA (1% SODIUM HYALURONATE)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Solo Smart Heart Valve

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Perceval Sutureless Heart Valve and Perceval PLUS Sutureless Heart Valve

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval
FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·PROPEL SINUS IMPLANT