10,000 results · 48ms · Sources: EU EUDAMED, US FDA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW L V Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Seren

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·SELECTSECURE LEAD

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

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-Ll (SP263) Assay

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·SNS URINARY INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·HYALGAN

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS AND EXPRESS2 CORONARY STENT SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Mynx Control and Mynx Grip Vascular Closure Device

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra AV TPS, Micra TPS

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

FDA Pre-Market Approval
FDA Class 3 ·CapSure SP Novus Lead, Vitatron Impulse II Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC DF4 PROTECTA XT/PROTECTA/SECURA/MAXIMO II VR/DR ICDS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS FAMILIES OF ICDS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX