8,847 results · 44ms · Sources: EU EUDAMED, US FDA

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Pre-Market Approval
FDA Class 3 ·remede® System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·3F AORTIC BIOPROSTHESIS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Revanesse Ultra (Revanesse Versa)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TREO Abdominal Stent-Graft System

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·OPTUNE

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

FDA Pre-Market Approval
FDA Class 3 ·Natrelle Silicone-Filled Breast Implants

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

FDA Pre-Market Approval
FDA Class 3 ·QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPENDANCE CONTOLLED ENDOMETRIAL ABLATION SYSTEM

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Aorfix AAA Flexible Stent Graft System with Aorflex Delivery Device

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON PTA CATETER

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier-Edwards PERIMOUNT, Plus, Theon, RSR, Magna,Magna Ease, Mega Mitral Pericardial Aortic Bioprosthesis with Ther

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·IDEAL IMPLANT SALINE FILLED BREAST IMPLANT

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Attain Ability MRI SureScan Lead, Attain Ability Plus MRI SureScan Lead, Attain Ability Straight MRI SureScan Lead, Atta

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Sentus QP Pacing Leads