1,221 results · 27ms · Sources: EU EUDAMED, US FDA

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS AND EXPRESS CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERFLEX (LIBERTE) CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

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

FDA Pre-Market Approval
FDA Class 3 ·TactiCath Contact Force Ablation Catheter, Sensor Enabled

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED™ Absorbable Adhesion Barrier

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Thoracic Stent Graft with the Captivia Delivery System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Endurant Stent Graft System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CapSureFix MRI Lead

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

FDA Pre-Market Approval
FDA Class 3 ·CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, VERSA, SENSIA IPD; RELIA IPG.

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL® ORIGINAL Absorbable Hemostat, SURGICEL® NU-KNIT™ Absorbable Hemostat, SURGICEL® SNOW™ Absorbable Hemostat

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·MENTOR SALINE-FILLED AND SPECTRUM MAMMARY PROSTHESES

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEl BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS