3,100 results · 18ms · Sources: EU EUDAMED, US FDA

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·IDEAL IMPLANT® Structured Breast Implant

Device, Dermal Replacement

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA COMPANION 2 DRIVER SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT

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

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

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC -L TOTAL DISC REPLACEMENT DEVICE

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ENDOTEX NEXSTENT CAROTID STENT AND MONORAIL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR THERMOCOOL

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Innova Self-Expanding Stent System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Inspiris Resilia Aortic Valve

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR

Diagnostic Low Electric Field

FDA Pre-Market Approval
FDA Class 3 ·MarginProbe System

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

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

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Orbera Intragastric Balloon

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

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM