10,000 results · 42ms · Sources: EU EUDAMED, US FDA

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·FALOPE-RING BAND AND APPLICATOR SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·LOTUS Edge Valve System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock Modified Orifice Valved Conduit

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE

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

FDA Pre-Market Approval
FDA Class 3 ·CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·St.Jude Medical Biocor, Epic and Epic Supra Valves

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES.

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER & AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER-CRIBRIFORM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·INSYNC CRT-P/INSYNC III CRT-P

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·FINELINE II/THINLINE II

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·BETA-CATH SYSTEM

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY