12 results · 44ms · 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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MO & OTW

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS SAV AORTIC PORCINE BIOPROSTHESIS

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Storz Medical Duolith SD1 Shock Wave Therapy Device

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA Pre-Market Approval
FDA Class 3 ·Optune Lua

Transvenous Temporary Phrenic Nerve Stimulator

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

FDA Pre-Market Approval
MediBeacon® Transdermal GFR Measurement System (TGFR)

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA Pre-Market Approval
FDA Class 3 ·Optune Lua

Transvenous Temporary Phrenic Nerve Stimulator

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Saluda Medical Evoke® SCS System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6