5,480 results · 29ms · Sources: EU EUDAMED, US FDA

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED II INFUSION PUMP

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNVISC AND SYNVISC-ONE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510

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

FDA Pre-Market Approval
FDA Class 3 ·CapSure SP Novus Lead 5092, 5592, 5594; CapSure Z Novus Lead 5054, 5554

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·EXCOR Blood pump

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

FDA Pre-Market Approval
FDA Class 3 ·TACTICATH QUARTZ SET

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Aortic Root Bioprosthesis

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·PRECISE NITINOL STENT SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas BRAF V600 Mutation Test

Pulse Generator, Permanent, Implantable

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

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DURASPHERE INJECTABLE BULKING AGENT

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK LOWPOROSITY VALVED CONDUIT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX MRI SURESCAN LEAD

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN Ultrasound Bone Healing System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN BIPOLAR OTW/OTW/CS LEAD

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·Rotablator™and ROTAPRO™ Rotational Atherectomy System, RotaWire™ Guidewire and wireClip™ Torquer, ROTAWIRE™ Drive Guidew

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·LEAD ASSEMBLY

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CT Lucia 602